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Data / Medical devices / United States / Philips North America LLC

Philips North America LLC: FDA-registered device maker in Export, PA, United States, 7 510(k) clearances

Philips North America LLC is registered with the FDA (registration 3016701404) in Export, PA, United States. It lists 41 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 14, 2016. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Philips North America LLC
FDA registration number
3016701404
Address
1003 Corporate Lane STE B, Export, PA, United States, 15632
Owner or operator
Philips Medical Systems International BV (1217116)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
March 11, 2009
Registered through
2026
Brand names listed
12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951, 2-CH Patch, 40494E, Limb Clamp Electrode, 453564588501, Transpac IV Dual IBP Cable, 867030, IntelliVue Multi-Measurement Module X3, 867033, IntelliVue Patient Monitor MX100, 867036, IntelliVue Multi-Measurement Module MMX, 867039, IntelliVue Hemodynamic Extension and more

Devices it lists

DeviceProduct codeClassRoleSource
Alarm, Blood-PressureDSJ2Contract manufactureraccessdata.fda.gov
Amplifier And Signal Conditioner, Transducer SignalDRQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Contract manufactureraccessdata.fda.gov
Analyzer, Spectrum, Electroencephalogram SignalGWS1Contract manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Contract manufactureraccessdata.fda.gov
Calculator, Pulmonary Function DataBZC2Contract manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Repackager or relabeleraccessdata.fda.gov
Computer, Blood-PressureDSK2Contract manufactureraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Contract manufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Contract manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Contract manufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Contract manufactureraccessdata.fda.gov
Display, Cathode-Ray Tube, MedicalDXJ2Contract manufactureraccessdata.fda.gov
ElectrocardiographDPS2Contract manufactureraccessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)MWJ2Contract manufactureraccessdata.fda.gov
Electrocardiograph, Ambulatory, With Analysis AlgorithmMLO2Contract manufactureraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Repackager or relabeleraccessdata.fda.gov
Full-Montage Standard ElectroencephalographGWQ2Contract manufactureraccessdata.fda.gov
Medical Device Data SystemOUG1Contract manufactureraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Contract manufactureraccessdata.fda.gov
Monitor, Carbon-Dioxide, CutaneousLKD2Contract manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Contract manufactureraccessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaKLK2Contract manufactureraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Contract manufactureraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Contract manufactureraccessdata.fda.gov
OximeterDQA2Contract manufactureraccessdata.fda.gov
Recorder, Magnetic Tape, MedicalDSH2Contract manufactureraccessdata.fda.gov
Recorder, Paper ChartDSF1Contract manufactureraccessdata.fda.gov
Stimulator, Nerve, Peripheral, ElectricKOI2Contract manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Contract manufactureraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Contract manufactureraccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Contract manufactureraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 14, 2016K162343Westmed Gas Sampling Cannula with O2 deliveryCCKSubstantially EquivalentWestmed, Inc.accessdata.fda.gov
March 10, 2016K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesCCKSubstantially EquivalentSalter Labsaccessdata.fda.gov
December 23, 2015K152330Expression MR400 MRI Patient Monitoring SystemMWISubstantially EquivalentInvivo Corporationaccessdata.fda.gov
July 15, 2013K131382EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTALMWISubstantially EquivalentInvivo Corporationaccessdata.fda.gov
February 22, 2013K124061MRI PATIENT MONITORING SYSTEM (MODEL 865214)MWISubstantially EquivalentInvivo Corporationaccessdata.fda.gov
December 15, 2009K090785MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214MWISubstantially EquivalentInvivo Corp.accessdata.fda.gov
September 19, 2006K061573TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KITDRSSubstantially EquivalentHospira, Inc.accessdata.fda.gov

Compare with other makers

Updated December 14, 2016. 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.