Data / Medical devices / Germany / Philips Medizin Systeme Boeblingen GmbH

Philips Medizin Systeme Boeblingen GmbH: FDA-registered device maker in BOEBLINGEN Baden-Wurttemberg, Germany, 91 510(k) clearances

Name: Philips Medizin Systeme Boeblingen GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Medizin Systeme Boeblingen GmbH is registered with the FDA (registration 9610816) in BOEBLINGEN Baden-Wurttemberg, Germany. It lists 76 device types. The FDA files 91 510(k) clearances under its listings, the newest dated March 30, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Philips Medizin Systeme Boeblingen GmbH

FDA registration number: 9610816
FEI number: 3002807167
Address: Hewlett-Packard Strasse 2, BOEBLINGEN Baden-Wurttemberg, Germany, D 71034
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: October 13, 1992
Registered through: 2026
Brand names listed: 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951, 13943B Solid Gel Tab Electrode, Resting ECG, 15mm Male/Female Adapter, 15mm Male/Female Adapter Low Deadspace, 2-CH Patch, 40457C Chemical/Thermal Paper, 40477A Chemical/Thermal Paper, 40494E, Limb Clamp Electrode and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Lead Switching, Electrocardiograph	DRW	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Alarm, Blood-Pressure	DSJ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Amplifier And Signal Conditioner, Transducer Signal	DRQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Spectrum, Electroencephalogram Signal	GWS	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Antimicrobial Blood Pressure Cuff	OED	2	Complaint file establishment, Exporter to the US, Specification developer	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Cable, Electrode	IKD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Calculator, Pulmonary Function Data	BZC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Complaint file establishment, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Display, Cathode-Ray Tube, Medical	DXJ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Electrocardiograph	DPS	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)	MWJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Gas, Calibration (Specified Concentration)	BXK	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Generator, Electroencephalograph Test Signal	GWR	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Medical Device Data System	OUG	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Carbon-Dioxide, Cutaneous	LKD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Monitor, St Segment	MLC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Uterine Contraction, External (For Use In Clinic)	HFM	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ph Rate Measurement, Carbon-Dioxide	JFL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	JOM	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Probe, Thermodilution	KRB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Recorder, Paper Chart	DSF	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Stethoscope Head	BZS	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Balloon, Intra-Aortic And Control	DSP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Signal Isolation	DRJ	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Tester, Electrode, Surface, Electrocardiographic	KRC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Pressure, Intrauterine	HFN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Obstetric	HGL	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Urinometer, Electrical	EXS	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Uterine Electromyographic Monitor	OSP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 30, 2026	K253654	IntelliVue Measurement Rack 6000 (867317)	MSX	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
February 6, 2026	K252726	IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 10, 2025	K251702	IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )	MHX	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
October 17, 2025	K251146	IntelliVue Patient monitors MX400, MX450, MX500, MX550	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
September 2, 2025	K250453	IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)	MHX	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
May 5, 2025	K242962	Telemetry Monitor 5500 Release 4.0 (867232)	MHX	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
January 17, 2025	K243545	Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn	DSA	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
December 17, 2024	K241556	Cardiac Workstation (5000); Cardiac Workstation (7000)	DPS	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
July 2, 2024	K233440	Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)	HGM	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
December 19, 2023	K231671	IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 22, 2023	K230604	IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
August 22, 2023	K223574	IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
February 3, 2023	K221348	IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)	MHX	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
December 2, 2022	K221141	PageWriter TC35 Cardiograph	DPS	Substantially Equivalent	Medizin Systeme Boblingen GmbH	accessdata.fda.gov
March 4, 2022	K211900	Patient Information Center iX	MHX	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH	accessdata.fda.gov
October 7, 2021	K210906	IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
September 30, 2021	K212227	Philips MR Patient Care Portal	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
September 30, 2021	K212208	Philips IntelliVue GuardianSoftware (Rev. E.0X)	DXJ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
September 11, 2020	K192137	IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 19, 2019	K182979	IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
October 27, 2019	K190624	EarlyVue VS30	DSJ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
April 26, 2019	K182637	Philips IntelliVue XDS Software	MSX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 15, 2018	K181831	IntelliVue Multi-Measurement Module MMX	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
September 10, 2018	K173941	IntelliSpace Perinatal Rev.K.00	HGM	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
July 16, 2018	K180534	Philips IntelliVue GuardianSoftware	DXJ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
December 26, 2017	K172904	IntelliVue Capnography Extension, IntelliVue Microstream Extension	CCK	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
October 6, 2017	K171801	IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
January 27, 2017	K161767	Philips IntelliVue GuardianSoftware	DXJ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
December 28, 2016	K162675	Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
July 1, 2016	K161531	IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
December 23, 2015	K152330	Expression MR400 MRI Patient Monitoring System	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
October 21, 2015	K151736	Philips IntelliVue GuardianSoftware	DXJ	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH	accessdata.fda.gov
July 17, 2015	K151681	IntelliVue Patient Monitor	DSI	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
June 25, 2015	K150975	Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 25, 2014	K140535	PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50	HGM	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH	accessdata.fda.gov
November 26, 2013	K131913	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	DRG	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
October 17, 2013	K131872	INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
August 16, 2013	K131829	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
July 15, 2013	K131382	EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
June 14, 2013	K130849	INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
April 12, 2013	K122223	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	BZQ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
February 22, 2013	K124061	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
August 29, 2012	K122439	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
July 18, 2012	K121638	ST80I STRESS TEST SYSTEM	DQK	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
July 18, 2012	K120366	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
June 29, 2012	K120855	INTELLISPACE ECG	DQK	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
April 3, 2012	K113144	PAGEWRITER TC 20, 30, 50, 70	DPS	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
March 22, 2012	K113657	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH	accessdata.fda.gov
March 22, 2012	K113441	PHYSIOLOGICAL MONITOR, PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
September 30, 2011	K110474	PHILIPS INTELLIVUE TCG10	LKD	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
March 31, 2011	K110622	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
March 15, 2011	K103700	ESSENTIAL MRI PATIENT MONITOR	DQA	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
February 15, 2011	K110287	PHILIPS ECG LEADWIRE SET	DSA	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
October 26, 2010	K101571	XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS	MWI	Substantially Equivalent	Witt Biomedical Corp	accessdata.fda.gov
August 31, 2010	K101600	INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL	DQA	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
December 15, 2009	K090785	MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214	MWI	Substantially Equivalent	Invivo Corp.	accessdata.fda.gov
September 22, 2009	K091572	DISPOSABLE SPO2 SENSOR M1134A	DQA	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
August 21, 2009	K092291	SKINTACT AND VARIOUS OTHER TRADENAMES	DRX	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
May 4, 2009	K090360	PHILIPS M3001A MULTI MEASUREMENT SERVER	DQA	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH	accessdata.fda.gov
February 25, 2009	K082583	INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
October 3, 2008	K082633	INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90	DSI	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
May 9, 2008	K080999	PAGEWRITER CARDIOGRAPH	DPS	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
December 20, 2007	K071885	ANTIMICROBIAL AND SINGLE-PATIENT CUFFS	OED	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
July 24, 2007	K071733	DL900 SERIES HOLTER RECORDER	MWJ	Substantially Equivalent	Braemar, Inc.	accessdata.fda.gov
November 9, 2006	K062605	PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T	DQA	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
November 3, 2006	K062455	PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL	DQA	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
February 17, 2006	K060221	THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
January 10, 2006	K053522	PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 17, 2005	K052377	PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.	DQA	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
April 22, 2005	K050762	PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
December 22, 2004	K040971	GENCHEM ISE ELECTROLYTE REFERENCE	JGS	Substantially Equivalent	Genchem, Inc.	accessdata.fda.gov
October 15, 2004	K042306	PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A	DQA	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
April 29, 2004	K040917	PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B	CBQ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
April 22, 2004	K040259	MASIMO SET INTELLIVUE PULSE OXIMETER MODULE	DQA	Substantially Equivalent	Masimo Corp.	accessdata.fda.gov
February 20, 2004	K032979	PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T	DQA	Substantially Equivalent	Philips Medical Systems, Inc.	accessdata.fda.gov
October 10, 2003	K032858	THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.	DSI	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH	accessdata.fda.gov
July 23, 2003	K030973	PICOSAT II SPO2 PULSE OXIMETRY MODULE	DQA	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
February 24, 2003	K023931	PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A	HGM	Substantially Equivalent	Philips Medical Systems, Inc.	accessdata.fda.gov
July 17, 2002	K021778	PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B	DQA	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
May 8, 2002	K021300	MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B	DSI	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
November 28, 2001	K013199	PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B	MHX	Substantially Equivalent	Philips Medical Systems, Inc.	accessdata.fda.gov
December 15, 2000	K003038	AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A	OLW	Substantially Equivalent	Agilent Technologies Deutschland GmbH	accessdata.fda.gov
May 17, 2000	K001333	AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI	DSI	Substantially Equivalent	Agilent Technologies Deutschland GmbH	accessdata.fda.gov
February 3, 2000	K993383	HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B	DSI	Substantially Equivalent	Hewlett-Packard GmbH	accessdata.fda.gov
November 8, 1999	K992674	HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A	MHX	Substantially Equivalent	Hewlett-Packard GmbH	accessdata.fda.gov
March 23, 1998	K971910	MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)	DSI	Substantially Equivalent	Hewlett-Packard GmbH	accessdata.fda.gov
December 3, 1997	K973437	HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES	DPS	Substantially Equivalent	Hewlett-Packard GmbH	accessdata.fda.gov
July 29, 1993	K925910	HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE	KLK	Substantially Equivalent	Hewlett-Packard Co.	accessdata.fda.gov
December 20, 1990	K905101	NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF	DXQ	Substantially Equivalent	Hewlett-Packard Co.	accessdata.fda.gov
July 24, 1989	K892355	M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ	IYO	Substantially Equivalent	Hewlett-Packard Co.	accessdata.fda.gov
January 19, 1989	K882609	MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM	DRT	Substantially Equivalent	Waltham Div. Hewlett Packard	accessdata.fda.gov

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Updated March 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.