Data / Medical devices / Netherlands / CEVA LOGISTICS NETHERLANDS BV (Venray)

CEVA LOGISTICS NETHERLANDS BV (Venray): FDA-registered device maker in Oostrum Limburgh, Netherlands, 146 510(k) clearances

Name: CEVA LOGISTICS NETHERLANDS BV (Venray) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CEVA LOGISTICS NETHERLANDS BV (Venray) is registered with the FDA (registration 3018783526) in Oostrum Limburgh, Netherlands. It lists 61 device types. The FDA files 146 510(k) clearances under its listings, the newest dated December 30, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch CEVA LOGISTICS NETHERLANDS BV (Venray)

FDA registration number: 3018783526
Address: Edisonstraat 2-6, Oostrum Limburgh, Netherlands, 5807 GG
Owner or operator: CEVA Logistics Netherlands BV (10086416)
Roles: Exporter to the US
First device listed: November 8, 2022
Registered through: 2026
Brand names listed: ADULT AIRWAY ADAPTER, QTY 1, MAQUET, AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10, AOM (RIMR), Actiware, Actiwatch Spectrum Pro/Plus, Actiwatch Spectrum Pro/Plus + Dock, Adult Nasal/Oral CO2 Cannula Capnoflex, Airway Adapter - Single Patient Use - Adult/Pediatric and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Oropharyngeal, Anesthesiology	CAE	1	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Exporter to the US	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Exporter to the US	accessdata.fda.gov
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Exporter to the US	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Exporter to the US	accessdata.fda.gov
Calculator, Pulmonary Function Data	BZC	2	Exporter to the US	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Exporter to the US	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Exporter to the US	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Exporter to the US	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Exporter to the US	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use Ventilator	MNT	2	Exporter to the US	accessdata.fda.gov
Continuous, Ventilator, Home Use	NOU	2	Exporter to the US	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Exporter to the US	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Exporter to the US	accessdata.fda.gov
Device, Biofeedback	HCC	2	Exporter to the US	accessdata.fda.gov
Device, Positive Pressure Breathing, Intermittent	NHJ	2	Exporter to the US	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Exerciser, Measuring	ISD	2	Exporter to the US	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Exporter to the US	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Exporter to the US	accessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Exporter to the US	accessdata.fda.gov
Holding Chambers, Direct Patient Interface	NVP	2	Exporter to the US	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Exporter to the US	accessdata.fda.gov
Intra-Pulmonary Percussive Vibration (Ipv) Devices	SDT	2	Exporter to the US	accessdata.fda.gov
Mask, Oxygen	BYG	1	Exporter to the US	accessdata.fda.gov
Medical Device Data System	OUG	1	Exporter to the US	accessdata.fda.gov
Meter, Peak Flow, Spirometry	BZH	2	Exporter to the US	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Exporter to the US	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Exporter to the US	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Exporter to the US	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Exporter to the US	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Percussor, Powered-Electric	BYI	2	Exporter to the US	accessdata.fda.gov
Pillow, Cervical (For Mild Sleep Apnea)	MYB	2	Exporter to the US	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Exporter to the US	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Exporter to the US	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Exporter to the US	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Exporter to the US	accessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)	BZK	2	Exporter to the US	accessdata.fda.gov
Spirometer, Therapeutic (Incentive)	BWF	2	Exporter to the US	accessdata.fda.gov
Stand, Infusion	FOX	1	Exporter to the US	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Exporter to the US	accessdata.fda.gov
Strap, Head, Gas Mask	BTK	1	Exporter to the US	accessdata.fda.gov
System, Communication, Powered	ILQ	2	Exporter to the US	accessdata.fda.gov
System, Isokinetic Testing And Evaluation	IKK	2	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Transducer, Gas Flow	BXP	1	Exporter to the US	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Exporter to the US	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Exporter to the US	accessdata.fda.gov
Ventilator, Continuous, Non-Life-Supporting	MNS	2	Exporter to the US	accessdata.fda.gov
Ventilator, External Body, Negative Pressure, Adult (Cuirass)	BYT	2	Exporter to the US	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Exporter to the US	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Exporter to the US	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. Newest 100 of 146.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 30, 2024	K243394	AF531 Oro-Nasal SE Face Mask	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 31, 2024	K233555	AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask	BZD	Substantially Equivalent	Philips Respironics	accessdata.fda.gov
August 24, 2021	K210844	DreamWear Silicone Pillows Mask	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 12, 2021	K210386	Magneto Nasal Mask	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 29, 2020	K202142	Sleepware G3	OLZ	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
September 25, 2020	K201439	Ventilator, Non-continuous (Respirator)	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 10, 2020	K200480	DreamStation 2 System, DreamStation 2 Advanced System	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
May 4, 2020	K193228	Hamilton-G5	CBK	Substantially Equivalent	Hamilton Medical AG	accessdata.fda.gov
October 18, 2019	K183226	Care Orchestrator Essence	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
August 2, 2019	K181216	HAMILTON-T1, HAMILTON-C1	CBK	Substantially Equivalent	Hamilton Medical AG	accessdata.fda.gov
July 18, 2019	K181170	Trilogy Evo Universal	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 18, 2019	K181166	Trilogy Evo	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
March 19, 2019	K180098	SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1	CBK	Substantially Equivalent	Maquet Critical Care AB	accessdata.fda.gov
June 5, 2018	K180608	Lunoa System	MYB	Substantially Equivalent	Nightbalance BV	accessdata.fda.gov
November 2, 2017	K170853	InnoSpire Go	CAF	Substantially Equivalent	Respironics Respiratory Drug Delivery (Uk) , Ltd.	accessdata.fda.gov
August 2, 2017	K162832	731 Series Ventilators	CBK	Substantially Equivalent	ZOLL Medical Corporation	accessdata.fda.gov
April 15, 2016	K151120	Simple T Pediatric Nasal Mask	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
September 18, 2015	K150639	AF541 EE Full Face Mask	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
September 18, 2015	K150638	AF541 SE Full Face Mask	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
February 10, 2015	K140980	TI NASAL MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
January 9, 2015	K142554	Revolution Full Face Mask	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
November 14, 2014	K140424	RESPIRONICS REUSABLE HEATED TUBING	BZE	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 20, 2014	K140268	SIMPLE T YOUTH NASAL MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 16, 2014	K140598	PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC	NHJ	Substantially Equivalent	Dima Italia Srl	accessdata.fda.gov
October 3, 2014	K140605	MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC	NHJ	Substantially Equivalent	Dima Italia Srl	accessdata.fda.gov
June 20, 2014	K123149	SERVO-I VENTILATOR SYSTEM	CBK	Substantially Equivalent	Maquet Critical Care AB	accessdata.fda.gov
November 20, 2013	K132168	BRONCHOSCOPY ELBOW	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 18, 2013	K131982	REMSTAR AUTO A-FLEX HT	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
May 21, 2013	K130077	REMSTAR SE	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
March 6, 2013	K122847	KANGAROO NASAL MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 31, 2012	K122111	RESPIRONICS SIMPLYCLEAR DEVICE	SDT	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 14, 2012	K121955	COUGHASSIST T70 DEVICE	NHJ	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 14, 2012	K121623	BIPAP A 40 VENTILATORY SUPPORT SYSTEM	MNT	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 9, 2012	K122769	REMSTAR SE	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 5, 2012	K121631	SIMPLE T NASAL MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 17, 2012	K120562	PERFORMAX PEDIATRIC EE TOTAL FACE MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 10, 2012	K120639	PERFORMAX PEDIATRIC SE TOTAL FACE MASK	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
February 1, 2012	K113053	BIPAP A 30 VENTILATORY SUPPORT SYSTEM	MNS	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 16, 2011	K113068	REMSTAR AUTO A-FLEX HT	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
November 4, 2011	K111885	SIMPLYGO PORTABLE OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 25, 2011	K102454	I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM	CAF	Substantially Equivalent	Respironics Respiratory Drug Delivery (Uk) , Ltd.	accessdata.fda.gov
October 14, 2011	K111610	TRILOGY SERIES VENTILATOR WITH OXIMETRY	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 4, 2011	K111378	OXIMETRY INTERFACE KIT	MNS	Substantially Equivalent	Philips Respironics, Inc.	accessdata.fda.gov
August 9, 2011	K110293	OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER	NVP	Substantially Equivalent	Respironics New Jersey, Inc.	accessdata.fda.gov
June 6, 2011	K110405	TRUBLUE NASAL MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
June 2, 2011	K103578	PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST	BZK	Substantially Equivalent	Respironics Novametrix, LLC	accessdata.fda.gov
June 1, 2011	K110398	RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS	BZE	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
April 5, 2011	K102985	V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS	MNT	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
March 24, 2011	K103395	PERFORMAX TOTAL FACE MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
March 24, 2011	K102465	BIPAP AVAPS VENTILATORY SUPPORT SYSTEM	MNS	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
November 10, 2010	K102240	NIVO NEBULIZER SYSTEM	CAF	Substantially Equivalent	Aerogen Ireland, Ltd.	accessdata.fda.gov
September 16, 2010	K101129	ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
September 2, 2010	K101130	BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK	MNS	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 9, 2010	K100428	MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
June 29, 2010	K100285	LITETOUCH MASK	CAF	Substantially Equivalent	Respironics New Jersey, Inc.	accessdata.fda.gov
May 12, 2010	K093905	TRILOGY 202 VENTILATOR	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
February 12, 2010	K092835	COMFORTGEL NASAL MASK	BZD	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
January 29, 2010	K093416	TRILOGY 200 VENTILATOR	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
January 22, 2010	K092818	BIPAP AVAPS VENTILATORY SUPPORT SYSTEM	MNS	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 18, 2009	K092648	RESPIRONICS PERFORMAX SE TOTAL FACE MASK	CBK	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
October 30, 2009	K090539	BIPAP AUTOSV ADVANCED	MNS	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
August 21, 2009	K092217	MERCURY VCO2	BZK	Substantially Equivalent	Respironics Novametrix, Inc.	accessdata.fda.gov
August 3, 2009	K091319	REMSTAR AUTO A-FLEX	BZD	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
July 28, 2009	K091459	PHILIPS NM3 MONITOR, MODEL 7900	BZK	Substantially Equivalent	Respironics Novametrix, LLC	accessdata.fda.gov
June 26, 2009	K090484	ALICE PDX	MNR	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
May 29, 2009	K091271	RESPIRONICS PERFORMAX TOTAL FACE MASK	BZD	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
May 8, 2009	K090243	REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM	BZD	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
March 25, 2009	K082558	COMFORTLITE NASAL MASK	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
March 23, 2009	K083750	CAPNOSTAT / CAPNOFLEX CO2 SYSTEM	MHX	Substantially Equivalent	Ge Medical Systems Information Technologies	accessdata.fda.gov
March 13, 2009	K083526	TRILOGY 100 VENTILATOR	CBK	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
January 30, 2009	K082866	REVOLUTIONFULL FACE MASK	BZD	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
January 26, 2009	K083874	GALAXY	MNR	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
January 9, 2009	K082660	V60 VENTILATOR, MODEL V8000	MNT	Substantially Equivalent	Respironics California, Inc.	accessdata.fda.gov
June 5, 2008	K081285	FINGER PULSE OXIMETER, MODEL 9560	DQA	Substantially Equivalent	Nonin Medical, Inc.	accessdata.fda.gov
May 29, 2008	K072290	PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS	BYT	Substantially Equivalent	Dima Italia Srl	accessdata.fda.gov
April 25, 2008	K073600	COMFORTGEL FULL FACE MASK	BZD	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
March 31, 2008	K073706	RESPIRATORY HUMIDIFIER, MODEL MR850	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
February 16, 2007	K062689	SIDESTREAM PLUS	CAF	Substantially Equivalent	Respironics , Ltd.	accessdata.fda.gov
June 28, 2006	K061261	L4 OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
June 23, 2006	K061034	BIPAP PLUS M-SERIES BI-LEVEL SYSTEM	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
June 22, 2006	K060404	AG-PLUS, MODEL 91210	CAF	Substantially Equivalent	Medel S.P.A.	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 12, 2006	K053174	LOFLO C5 CO2 SENSOR	CCK	Substantially Equivalent	Respironics Novametrix, LLC	accessdata.fda.gov
December 13, 2005	K053063	PRO-FLOW MULTIPURPOSE CANNULA	CCK	Substantially Equivalent	Pro-Tech Services, Inc.	accessdata.fda.gov
December 13, 2005	K052573	STARDUST II	MNR	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 9, 2005	K052941	I-NEB INSIGHT AAD SYSTEM	CAF	Substantially Equivalent	Profile Therapeutics Plc	accessdata.fda.gov
June 17, 2005	K051383	THE INCOURAGE SYSTEM	BYI	Substantially Equivalent	Respiratory Technologies, Incorporated	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
February 11, 2005	K043006	MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605	CAW	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
November 19, 2004	K042601	CAPNOSTAT 5	CCK	Substantially Equivalent	Respironics Novametrix, Inc.	accessdata.fda.gov
October 13, 2004	K042655	INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456	CAF	Substantially Equivalent	Respironics New Jersey, Inc.	accessdata.fda.gov
May 5, 2004	K041010	REMSTAR AUTO WITH C-FLEX CPAP SYSTEM	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
April 22, 2004	K033534	VITALSENSE	FLL	Substantially Equivalent	Mini-Mitter Co., Inc.	accessdata.fda.gov
March 18, 2004	K040595	ALICE 5	OLZ	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
February 6, 2004	K033823	RESPIRONICS CUSTOM II ORAL APPLIANCE	LRK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 4, 2003	K031124	POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR	MHX	Substantially Equivalent	Datex-Ohmeda, Inc.	accessdata.fda.gov
November 13, 2003	K032809	HOSPITAL SPACER	CAF	Substantially Equivalent	Respironics Healthscan, Inc.	accessdata.fda.gov
October 17, 2003	K030668	MODEL 3100 WRISTOX PULSE OXIMETER	DQA	Substantially Equivalent	Nonin Medical, Inc.	accessdata.fda.gov
April 25, 2003	K022294	APNEACHECK	MNR	Substantially Equivalent	Im Systems	accessdata.fda.gov
January 3, 2003	K023135	IMAGE3 SE DISPOSABLE FULL FACE MASK	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 30, 2024. 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.