Product Code: CBK FDA class 2 21 CFR 868.5895

Ventilator, Continuous, Facility Use

Anesthesiology

The Continuous Facility-Use Ventilator is an anesthesiology device designed for extended use in clinical facilities to provide continuous mechanical ventilation to patients who cannot breathe adequately on their own, supporting or replacing normal respiratory function. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBK, regulated under 21 CFR 868.5895, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting.

View on FDA

510(k)s

505

FEI Numbers

130

Registration Numbers

130

Unique Applicants

148

Years Active

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Basic Information

Product Code: CBK
Device Class: FDA class 2
Regulation Number: 868.5895
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 505 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253647	Evita (V800); Evita (V600)	May 07, 2026	Substantially Equivalent	Draegerwerk AG & CO Kgaa
K252663	Inbentus Versatile	Apr 14, 2026	Substantially Equivalent	Iconic Solutions by Murcia, SL
K251888	VPAP Pediatric Face Mask	Mar 12, 2026	Substantially Equivalent	Hsiner Co., Ltd.
K232365	Vivo 45 LS	Dec 19, 2025	Substantially Equivalent	Oconnell Regulatory Consultants, Inc.
K252173	F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full	Sep 10, 2025	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K243767	SV600, SV800 Ventilator	Aug 28, 2025	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K251133	AVEA disposable expiratory filter/water trap (11790)	May 08, 2025	Substantially Equivalent	Telesair, Inc.
K243394	AF531 Oro-Nasal SE Face Mask	Dec 30, 2024	Substantially Equivalent	Respironics, Inc.
K233486	731 Series Ventilator	Dec 13, 2024	Substantially Equivalent	ZOLL Medical Corporation
K223120	Ventoux VC2; Ventoux VC3	Dec 02, 2024	Substantially Equivalent	Flight Medical Innovations , Ltd.
K241135	RESPOND(R) Ventilator	Nov 13, 2024	Substantially Equivalent	Corvent Medical, Inc.
K241943	Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask	Aug 28, 2024	Substantially Equivalent	Sleepnet Corporation
K232836	Family of DIMAR DMAX NIV masks	Aug 14, 2024	Substantially Equivalent	Dimar S.P.A.
K240807	VM-2000	Aug 13, 2024	Substantially Equivalent	Ventis Medical, Inc.
K241520	Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask	Jun 27, 2024	Substantially Equivalent	Sleepnet Corporation
K231778	Nihon Kohden NKV-550 Series Ventilator System	Mar 01, 2024	Substantially Equivalent	Nihon Kohden Orangemed, LLC
K213098	Panther 5	Jul 20, 2023	Substantially Equivalent	Origin Medical Devices
K220107	Mindray SV600 Ventilator, Mindray SV800 Ventilator	Jun 16, 2023	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K222644	Nihon Kohden NKV-440 Ventilator System	May 31, 2023	Substantially Equivalent	Nihon Kohden Orangemed, Inc.
K222207	Babylog VN800, Babylog VN600	May 16, 2023	Substantially Equivalent	Draegerwerk AG & CO Kgaa
K222024	Evita V800, Evita V600	May 16, 2023	Substantially Equivalent	Draegerwerk AG & CO Kgaa
K201082	LTV2 Series Ventilators	Nov 10, 2021	Substantially Equivalent	Vyaire Medical, Inc.
K210384	CARESCAPE R860	Nov 04, 2021	Substantially Equivalent	Datex-Ohmeda, Inc.
K201874	Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1	Apr 20, 2021	Substantially Equivalent	Maquet Critical Care AB
K203449	F&P Visairo NIV Mask Range	Apr 14, 2021	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K201306	HAMILTON-C3	Feb 05, 2021	Substantially Equivalent	Hamilton Medical AG
K202970	Ventway Sparrow	Jan 29, 2021	Substantially Equivalent	Inovytech Medical Solutions , Ltd.
K201658	Hamilton-C6	Dec 11, 2020	Substantially Equivalent	Hamilton Medical AG
K193056	Puritan Bennett 980 Series Ventilator System	Nov 20, 2020	Substantially Equivalent	Covidien, LLC
K192604	Servo-air 4.0 Ventilator System	Jun 18, 2020	Substantially Equivalent	Maquet Critica Care AB
K193228	Hamilton-G5	May 04, 2020	Substantially Equivalent	Hamilton Medical AG
K192307	Nihon Kohden NKV-550 Series Ventilator System	Jan 10, 2020	Substantially Equivalent	Nihon Kohden Orangemed, Inc.
K183364	Bellavista	Sep 13, 2019	Substantially Equivalent	Imtmedical AG
K181216	HAMILTON-T1, HAMILTON-C1	Aug 02, 2019	Substantially Equivalent	Hamilton Medical AG
K180295	Hamilton-G5	Jul 30, 2019	Substantially Equivalent	Hamiton Medical AG
K190533	Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented	Jul 26, 2019	Substantially Equivalent	Sleepnet Corporation
K181170	Trilogy Evo Universal	Jul 18, 2019	Substantially Equivalent	Respironics, Inc.
K181166	Trilogy Evo	Jul 18, 2019	Substantially Equivalent	Respironics, Inc.
K180098	SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1	Mar 19, 2019	Substantially Equivalent	Maquet Critical Care AB
K180779	Savina 300	Jan 17, 2019	Substantially Equivalent	Dragerwerk AG & CO Kgaa
K181695	Nihon Kohden NKV-550 Series Ventilator System	Dec 07, 2018	Substantially Equivalent	Nihon Kohden Orangemed, Inc.
K173973	TV-100	Jul 20, 2018	Substantially Equivalent	Bio-Med Devices, Inc.
K172875	Astral 100/150	Apr 26, 2018	Substantially Equivalent	Resmed, Ltd.
K173060	F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version	Jan 25, 2018	Substantially Equivalent	Fisher and Paykel Healthcare Limited
K162738	Puritan Bennett 980 Ventilator System	Oct 27, 2017	Substantially Equivalent	Covidien
K170037	Breathe Technologies Life2000 Ventilation System	Aug 11, 2017	Substantially Equivalent	Breathe Technologies
K162832	731 Series Ventilators	Aug 02, 2017	Substantially Equivalent	ZOLL Medical Corporation
K163127	bellavista 1000	Jul 31, 2017	Substantially Equivalent	Imtmedical AG
K161450	HAMILTON-C3	Apr 27, 2017	Substantially Equivalent	Hamilton Medical AG
K162877	VOCSN Unified Respiratory System	Apr 07, 2017	Substantially Equivalent	Ventec Life Systems, Inc.
K153046	HAMILTON-MR1	Sep 06, 2016	Substantially Equivalent	Hamilton Medical AG
K152068	Astral 100/150	May 13, 2016	Substantially Equivalent	Resmed, Ltd.
K143035	Flight 60 Ventilator	Mar 30, 2016	Substantially Equivalent	Flight Medical Innovations , Ltd.
K151252	Puritan Bennett 840 Series Ventilator System	Mar 29, 2016	Substantially Equivalent	Covidien LP
K151814	SERVO-U Ventilator System, SERVO-n Ventilator System	Dec 21, 2015	Substantially Equivalent	Maquet Critical Care AB
K151901	AirView	Nov 05, 2015	Substantially Equivalent	Resmed, Ltd.
K150638	AF541 SE Full Face Mask	Sep 18, 2015	Substantially Equivalent	Respironics, Inc.
K140939	HAMILTON-T1,HAMILTON-C1	Sep 02, 2015	Substantially Equivalent	Hamilton Medical AG
K142679	CARESCAPE R860	Jun 12, 2015	Substantially Equivalent	Datex-Ohmeda, Inc.
K141943	BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM	Jun 12, 2015	Substantially Equivalent	Breathe Technologies
K140575	ENGSTROM CARESTATION, ENGSTROM PRO	Feb 03, 2015	Substantially Equivalent	Datex-Ohmeda, Inc.
K121886	SAVINA 300 SAVINA 300, COUNTRY VARIANTS	Aug 08, 2014	Substantially Equivalent	Draeger Medical GmbH
K123149	SERVO-I VENTILATOR SYSTEM	Jun 20, 2014	Substantially Equivalent	Maquet Critical Care AB
K133868	ASTRAL VENTILATOR	Jun 04, 2014	Substantially Equivalent	Resmed, Ltd.
K130171	FLIGHT 60 VENTILATOR	Apr 08, 2014	Substantially Equivalent	Flight Medical Innovations , Ltd.
K131252	PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM	Feb 24, 2014	Substantially Equivalent	Covidien
K122438	HAMILTON-MR1	Nov 20, 2013	Substantially Equivalent	Hamilton Medical AG
K130178	INSPIRATION VENTILATOR SYSTEM 5I/7I	Oct 29, 2013	Substantially Equivalent	eVent Medical, Ltd.
K131774	HAMILTON-G5	Oct 09, 2013	Substantially Equivalent	Hamilton Medical AG
K120931	CRITICAL CARE VENTILATOR	Jun 06, 2013	Substantially Equivalent	Oricare, Inc.
K122560	VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1	Mar 26, 2013	Substantially Equivalent	Pan-America Hyperbarics, Inc.
K123637	HAMILTON-C3	Dec 21, 2012	Substantially Equivalent	Hamilton Medical AG
K113743	EVOLUTION 3E VENTILATOR	Dec 18, 2012	Substantially Equivalent	Event Medical, Inc.
K120146	QUARK SERIES	Dec 11, 2012	Substantially Equivalent	Cosmed Srl
K121225	HAMILTON-C2	Nov 16, 2012	Substantially Equivalent	Hamilton Medical AG
K121891	NEWPORT AURA VENTILATOR	Nov 09, 2012	Substantially Equivalent	Newport Medical Instruments, Inc.
K121379	PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY	Oct 11, 2012	Substantially Equivalent	Airon Corporation
K120639	PERFORMAX PEDIATRIC SE TOTAL FACE MASK	Jul 10, 2012	Substantially Equivalent	Respironics, Inc.
K120726	FLIGHT 60 VENTILATOR	Jul 06, 2012	Substantially Equivalent	Flight Medical Innovations , Ltd.
K112754	IVENT101	Jun 15, 2012	Substantially Equivalent	Versamed Medical Systems , Ltd.
K112729	BLEASE700/900 SERIES VENTILATORS	Jun 11, 2012	Substantially Equivalent	Spacelabs Healthcare
K120574	HAMILTON-C1	May 30, 2012	Substantially Equivalent	Hamilton Medical AG
K120670	HAMILTON-T1	Apr 03, 2012	Substantially Equivalent	Hamilton Medical AG
K113051	SPACELABS ARKON ANESTHESIA WORKSTATION	Mar 22, 2012	Substantially Equivalent	Spacelabs Healthcare
K111473	UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR	Feb 16, 2012	Substantially Equivalent	Impact Instrumentation, Inc.
K112006	HAMILTON-TC1	Feb 09, 2012	Substantially Equivalent	Hamilton Medical AG
K111595	NEUMOVENT GRAPHNET	Jan 27, 2012	Substantially Equivalent	Tecme S.A.
K110083	V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE	Jan 13, 2012	Substantially Equivalent	Respironics California, Inc.
K111146	NEWPORT HT70 VENTILATOR	Dec 01, 2011	Substantially Equivalent	Newport Medical Instruments, Inc.
K103803	HAMILTON-G5	Nov 23, 2011	Substantially Equivalent	Hamilton Medical AG
K111683	FLIGHT 60 VENTILATOR	Oct 31, 2011	Substantially Equivalent	Flight Medical Innovations , Ltd.
K111610	TRILOGY SERIES VENTILATOR WITH OXIMETRY	Oct 14, 2011	Substantially Equivalent	Respironics, Inc.
K103625	OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE	Oct 06, 2011	Substantially Equivalent	Draeger Medical Systems, Inc.
K111116	ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000	Sep 09, 2011	Substantially Equivalent	Datex-Ohmeda
K110795	V200 INTELLI-TRAK OPTION	Aug 19, 2011	Substantially Equivalent	Respironics California, Inc.
K102120	NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202	Aug 12, 2011	Substantially Equivalent	Hsiner Co., Ltd.
K103211	AVEA VENTILATOR	May 12, 2011	Substantially Equivalent	Care Fusion
K103318	UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR	Apr 07, 2011	Substantially Equivalent	Impact Instrumentation, Inc.
K101850	SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION	Mar 02, 2011	Substantially Equivalent	Spacelabs Healthcare, Ltd.
K101643	MODEL LTV 1100 VENTILATOR	Jan 26, 2011	Substantially Equivalent	Care Fusion
K102775	HAMILTON-C2	Jan 21, 2011	Substantially Equivalent	Hamilton Medical AG
K102054	V200 VENTILATOR	Dec 22, 2010	Substantially Equivalent	Respironics California, Inc.
K101401	NEUMOVENT GRAPHNET MODEL 3179L1V	Dec 07, 2010	Substantially Equivalent	Tecme S.A.
K101129	ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK	Sep 16, 2010	Substantially Equivalent	Respironics, Inc.
K101803	NEWPORT E360 VENTILATOR	Sep 08, 2010	Substantially Equivalent	Newport Medical Instruments, Inc.
K100753	FLIGHT 60 VENTILATOR, MODEL F-60	Aug 20, 2010	Substantially Equivalent	Flight Medical , Ltd.
K093905	TRILOGY 202 VENTILATOR	May 12, 2010	Substantially Equivalent	Respironics, Inc.
K093094	VELA VENTILATOR	May 11, 2010	Substantially Equivalent	Cardinal Health 207, Inc.
K093886	ENGSTROM CARESTATION, ENGSTROM PRO	May 03, 2010	Substantially Equivalent	Datex-Ohmeda Inc., A Division of Instrumentarium C
K093632	INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE	Apr 05, 2010	Substantially Equivalent	Drager Medical AG & Co. Kgaa
K093633	INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE	Mar 30, 2010	Substantially Equivalent	Draegerwerk AG & CO Kgaa
K092847	840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION	Mar 11, 2010	Substantially Equivalent	Covidien, Formerly Nellcor Puritan Bennett, Inc.
K092148	HAMILTON-C2	Mar 04, 2010	Substantially Equivalent	Hamilton Medical AG
K093416	TRILOGY 200 VENTILATOR	Jan 29, 2010	Substantially Equivalent	Respironics, Inc.
K092263	ENDURAVENT-5 VENTILATOR	Jan 21, 2010	Substantially Equivalent	Providence Global Medical, Inc.
K092648	RESPIRONICS PERFORMAX SE TOTAL FACE MASK	Dec 18, 2009	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group
K092264	ATLANTIS HYPERBARIC CHAMBER VENTILATOR	Dec 17, 2009	Substantially Equivalent	Providence Global Medical, Inc.
K092135	MODIFICATION TO IVENT 101	Nov 23, 2009	Substantially Equivalent	Versamed Medical Systems , Ltd.
K090888	NEWPORT HT70 FAMILY OF VENTILATORS	Nov 18, 2009	Substantially Equivalent	Newport Medical Instruments, Inc.
K091238	UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+	Aug 13, 2009	Substantially Equivalent	Impact Instrumentation, Inc.
K090468	HAMILTON-C2	Jun 15, 2009	Substantially Equivalent	Hamilton Medical AG
K083693	PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840	Apr 02, 2009	Substantially Equivalent	Covidien, Formerly Nellcor Puritan Bennett, Inc.
K083688	PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR	Mar 18, 2009	Substantially Equivalent	Pulmonetic Systems, Inc.
K081845	IVENT101	Mar 16, 2009	Substantially Equivalent	Versamed Medical Systems, Inc.
K083526	TRILOGY 100 VENTILATOR	Mar 13, 2009	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group
K083122	HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041	Mar 04, 2009	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K082351	NEPTUNE HYPERBARIC VENTILATOR	Jan 02, 2009	Substantially Equivalent	Level-5, Inc.
K083050	EVITE XL	Dec 29, 2008	Substantially Equivalent	Draeger Medical AG & Co. KG
K082724	NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM	Dec 16, 2008	Substantially Equivalent	Newport Medical Instruments, Inc.
K071526	UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV	Dec 10, 2008	Substantially Equivalent	Impact Instrumentation, Inc.
K082600	OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)	Nov 26, 2008	Substantially Equivalent	Draeger Medical B.V.
K082966	PB 540 VENTILATOR	Oct 31, 2008	Substantially Equivalent	Covidien, Formerly Nellcor Puritan Bennett, Inc.
K072926	HELONTIX VENT	Oct 15, 2008	Substantially Equivalent	Linde Gas Therapeutics
K081670	THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK	Oct 09, 2008	Substantially Equivalent	Cardinal Health 207, Inc.
K081842	ENGSTROM CARESTATION, ENGSTROM PRO	Oct 03, 2008	Substantially Equivalent	Datex-Ohmeda, Inc.
K081521	MODIFICATION TO HAMILTON-G5	Sep 25, 2008	Substantially Equivalent	Hamilton Medical AG
K081743	CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS	Sep 22, 2008	Substantially Equivalent	Draeger Medical AG & Co. KG
K081837	AVEA VENTILATOR	Aug 13, 2008	Substantially Equivalent	Cardinal Health 207, Inc.
K080181	MODIFICATION TO GALILEO GOLD	Jun 24, 2008	Substantially Equivalent	Hamilton Medical AG
K073179	SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585	Jun 09, 2008	Substantially Equivalent	Maquet Critical Care AB
K073694	IVENT 2001 MRI CONDITIONAL	May 30, 2008	Substantially Equivalent	Versamed Medical Systems, Inc.
K072885	CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110	Apr 07, 2008	Substantially Equivalent	Draeger Medical AG & Co. KG
K072412	OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500	Feb 06, 2008	Substantially Equivalent	Drager Medical AG & Co. Kgaa
K073069	MODIFICATION TO AVEA VENTILATOR	Jan 25, 2008	Substantially Equivalent	Viasys Respiratory Care, Inc.
K072590	INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM	Jan 04, 2008	Substantially Equivalent	Event Medical, Inc.
K072588	PERFORMAX SE TOTAL FACE MASK	Dec 18, 2007	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group
K070899	PURITAN BENNETT LEGENDAIR XL2	Dec 13, 2007	Substantially Equivalent	Nellcor Puritan Bennett
K072450	ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000	Dec 12, 2007	Substantially Equivalent	Respironics California, Inc.
K070513	HAMILTON-G5	Nov 26, 2007	Substantially Equivalent	Hamilton Medical AG
K071194	RAPHAEL COLOR ASV VENTILATOR	Oct 18, 2007	Substantially Equivalent	Hamilton Medical AG
K070594	PALMTOP VENTILATOR, MODELS PTV-8, PTV-10	Aug 01, 2007	Substantially Equivalent	Pulmonetic Systems, Inc.
K071212	ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000	Jul 30, 2007	Substantially Equivalent	Respironics California, Inc.
K063806	SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED	May 17, 2007	Substantially Equivalent	Sleepnet Corporation
K063650	VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840	Feb 15, 2007	Substantially Equivalent	Puritan Bennett Corp.
K063404	SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800	Feb 15, 2007	Substantially Equivalent	Maquet Critical Care AB
K062793	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION	Feb 07, 2007	Substantially Equivalent	Maquet Critical Care AB
K062710	GE DATEX-OHMEDA ENGSTROM CARESTATION	Dec 08, 2006	Substantially Equivalent	Datex-Ohmeda, Inc.
K062267	OXYLOG 3000	Oct 31, 2006	Substantially Equivalent	Drager Medical B.V.
K062093	AVEA VENTILATOR	Sep 20, 2006	Substantially Equivalent	Viasys Respiratory Care, Inc.
K062019	RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD	Aug 17, 2006	Substantially Equivalent	Innomed Technologies, Inc./Respcare, Inc.
K061094	NEWPORT E500 WAVE VENTILATOR	Jul 28, 2006	Substantially Equivalent	Newport Medical Instruments, Inc.
K061090	GALILEO GOLD ASV	Jul 17, 2006	Substantially Equivalent	Hamilton Medical AG
K061627	MODIFICATION TO I VENT 201	Jun 29, 2006	Substantially Equivalent	Versamed Medical Systems, Inc.
K060705	CARINA HOME	Jun 14, 2006	Substantially Equivalent	Draeger Medical B.V.
K060862	GE DATEX-OHMEDA ENGSTROM CARESTATION	Jun 05, 2006	Substantially Equivalent	Datex-Ohmeda, Inc.
K060647	LTV 1200 VENTILATOR	May 25, 2006	Substantially Equivalent	Pulmonetic Systems, Inc.
K060549	AUTOMOBILE LIGHTER POWER CORD	May 04, 2006	Substantially Equivalent	Pulmonetic Systems, Inc.
K053388	MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION	Apr 04, 2006	Substantially Equivalent	Puritan Bennett Corp.
K053270	IVENT 201	Jan 27, 2006	Substantially Equivalent	Versamed Medical Systems, Inc.
K053502	NEWPORT E360 VENTILATOR	Jan 10, 2006	Substantially Equivalent	Newport Medical Instruments, Inc.
K052863	RAPHAEL COLOR	Jan 06, 2006	Substantially Equivalent	Hamilton Medical AG
K051895	GE DATEX-OHMEDA ENGSTROM CARESTATION	Sep 27, 2005	Substantially Equivalent	Datex-Ohmeda, Inc.
K052554	MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR	Sep 23, 2005	Substantially Equivalent	Versamed Medical Systems, Inc.
K051222	AV-S ANAESTHESIA VENTILATOR	Sep 23, 2005	Substantially Equivalent	Penlon Limited
K051767	LTV 1000 VENTILATOR	Jul 29, 2005	Substantially Equivalent	Pulmonetic Systems, Inc.
K051550	INSPIRATION VENTILATOR SYSTEM	Jul 12, 2005	Substantially Equivalent	eVent Medical, Ltd.
K051263	EVITAXL WITH OPTION SMARTCARE	Jul 12, 2005	Substantially Equivalent	Drager Medical AG & Co. Kgaa
K051262	ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000	Jul 08, 2005	Substantially Equivalent	Respironics California, Inc.
K050860	GE DATEX-OHMEDA CENTIVA/5 VENTILATOR	Jun 21, 2005	Substantially Equivalent	Datex-Ohmeda, Inc.
K050597	GE DATEX-OHMEDA ENGSTROM CARESTATION	Mar 25, 2005	Substantially Equivalent	Datex-Ohmeda, Inc.
K043085	MODIFICATION TO: PNEUTON VENTILATOR	Dec 20, 2004	Substantially Equivalent	Airon Corporation
K042468	IVENT 201 PORTABLE VENTILATOR	Nov 17, 2004	Substantially Equivalent	Versamed Medical Systems, Inc.
K040574	GALILEO GOLD	Oct 27, 2004	Substantially Equivalent	Hamilton Medical, Inc.
K041775	GE DATEX-OHMEDA ENGSTROM CARESTATION	Oct 26, 2004	Substantially Equivalent	Datex-Ohmeda, Inc.
K032922	CLARISSA INFANT NCPAP CANNULA	Sep 22, 2004	Substantially Equivalent	Airways Ltd., Inc.
K041524	GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM	Sep 20, 2004	Substantially Equivalent	Datex-Ohmeda, Inc.
K041223	MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E	Jul 29, 2004	Substantially Equivalent	Maquet Critical Care AB
K041412	ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000	Jun 18, 2004	Substantially Equivalent	Respironics California, Inc.
K040790	MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS	Jun 03, 2004	Substantially Equivalent	Pulmonetic Systems, Inc.
K040642	LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA	Jun 02, 2004	Substantially Equivalent	Draeget Medical AG & Co. Kgaa
K040540	MODIFICATION TO LTV 1000 VENTILATOR	Apr 29, 2004	Substantially Equivalent	Pulmonetic Systems, Inc.
K032451	BIRD TBIRD VELA VENTILATOR	Mar 17, 2004	Substantially Equivalent	Bird Products Corp.
K040221	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E	Feb 20, 2004	Substantially Equivalent	Maquet Critical Care AB
K030780	NEWPORT E500 WAVE VENTILATOR	Jan 23, 2004	Substantially Equivalent	Newport Medical Instruments, Inc.
K034040	ESPRIT VENTILATOR, MODEL V1000	Jan 21, 2004	Substantially Equivalent	Respironics, Inc.
K030341	MODIFICATION TO INSPIRATION VENTILATOR SYSTEM	Jan 16, 2004	Substantially Equivalent	eVent Medical, Ltd.
K022679	RAPHAEL	Oct 22, 2003	Substantially Equivalent	Hamilton Medical AG
K032226	LTV-1000 VENTILATOR	Oct 16, 2003	Substantially Equivalent	Pulmonetic Systems, Inc.
K023366	DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS	Oct 07, 2003	Substantially Equivalent	Datex-Ohmeda, Inc.
K024344	PNEUTON VENTILATOR	Jun 03, 2003	Substantially Equivalent	Airon Corporation
K030515	HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS	May 02, 2003	Substantially Equivalent	Hans Rudolph, Inc.
K023289	OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072	Jan 15, 2003	Substantially Equivalent	Drager Medizintechnik GmbH
K023135	IMAGE3 SE DISPOSABLE FULL FACE MASK	Jan 03, 2003	Substantially Equivalent	Respironics, Inc.
K012691	MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES	Dec 20, 2002	Substantially Equivalent	Acutronic Medical Systems AG
K021112	INSPIRATION VENTILATOR SYSTEM	Nov 22, 2002	Substantially Equivalent	eVent Medical, Ltd.
K023350	ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS	Nov 06, 2002	Substantially Equivalent	Respironics California, Inc.
K022674	BIRD AVEA VENTILATOR	Nov 06, 2002	Substantially Equivalent	Bird Products Corp.
K022132	SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E	Sep 19, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K021573	PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION	Aug 13, 2002	Substantially Equivalent - Subject to Tracking Reg.	Puritan-Bennett
K012693	MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES	Aug 01, 2002	Substantially Equivalent	Acutronic Medical Systems AG
K013642	AVEA	May 22, 2002	Substantially Equivalent	Bird Products Corp.
K020746	BIRD TBIRD VELA VENTILATOR	Apr 22, 2002	Substantially Equivalent	Bird Products Corp.
K010793	OXYLOG 1000, MODEL 2M86840	Dec 20, 2001	Substantially Equivalent	Drager Medizintechnik GmbH
K010925	SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E	Dec 18, 2001	Substantially Equivalent	Siemens Elema AB
K012177	VENTVIEW, MODEL 8414095	Sep 04, 2001	Substantially Equivalent	Drager Medizintechnik GmbH
K010317	AV 800 VENTILATOR	Jul 23, 2001	Substantially Equivalent	Penlon , Ltd.
K011957	IVENT 201 PORTABLE VENTILATOR	Jul 18, 2001	Substantially Equivalent	Versamed , Ltd.
K003068	SAVINA	Jun 25, 2001	Substantially Equivalent	Drager Medizintechnik GmbH
K010093	NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474	Jun 14, 2001	Substantially Equivalent	Drager Medizintechnik GmbH
K010608	MODIFICATION TO LAP TOP VENTILATOR (LTV)	Mar 20, 2001	Substantially Equivalent	Pulmonetic Systems, Inc.
K003770	BIRD TBIRD LEGACY VENTILATOR	Dec 15, 2000	Substantially Equivalent - Subject to Tracking Reg.	Bird Products Corp.
K002951	MAGELLAN VENTILATOR	Dec 08, 2000	Substantially Equivalent	Oceanic Medical Products, Inc.
K001646	PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION	Oct 20, 2000	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K002686	ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E	Oct 18, 2000	Substantially Equivalent - Subject to Tracking Reg.	Nellcor Puritan Bennett, Inc.
K002881	VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000	Oct 11, 2000	Substantially Equivalent - Subject to Tracking Reg.	Pulmonetic Systems, Inc.
K992133	NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL	Aug 04, 2000	Substantially Equivalent - Subject to Tracking Reg.	Newport Medical Instruments, Inc.
K001686	GALILEO VENTILATOR	Jun 23, 2000	Substantially Equivalent - Subject to Tracking Reg.	Hamilton Medical, Inc.
K001208	ESPIRT	May 12, 2000	Substantially Equivalent	Respironics, Inc.
K993449	BIRD V.I.P. GOLD/STERLING	Dec 20, 1999	Substantially Equivalent - Subject to Tracking Reg.	Bird Products Corp.
K993071	PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840	Nov 24, 1999	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K990177	NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR	Nov 18, 1999	Substantially Equivalent - Subject to Tracking Reg.	Nellcor Puritan Bennett, Inc.
K993167	MILLENNIUM INFANT VENTILATOR	Nov 10, 1999	Substantially Equivalent - Subject to Tracking Reg.	Sechrist Industries, Inc.
K972833	E100M VENTILATOR (E100M)	Sep 23, 1999	Substantially Equivalent	Newport Medical Instruments, Inc.
K992670	OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067	Sep 17, 1999	Substantially Equivalent - Subject to Tracking Reg.	Instrumentation Industries, Inc.
K992788	BEAR CUB 750 PSV	Sep 16, 1999	Substantially Equivalent	Bear Medical Systems, Inc.
K982910	HAMILTON MEDICAL GALILEOVENTILATOR	Sep 14, 1999	Substantially Equivalent - Subject to Tracking Reg.	Hamilton Medical, Inc.
K992608	ATC OPTION FOR EVITA 2 DURA AND EVITA 4	Aug 24, 1999	Substantially Equivalent	Drager, Inc.
K982132	BLEASE 6200 ANAESTHESIA VENTILATOR	Apr 15, 1999	Substantially Equivalent	Blease Medical Equipment , Ltd.
K984056	LTV 1000	Apr 12, 1999	Substantially Equivalent	Pulmonetic Systems, Inc.
K981668	SMARTVENT 201 PORTABLE VENTILATOR	Apr 07, 1999	Substantially Equivalent	Versamed , Ltd.
K990429	MODIFICATION OF VENTURI VENTILATOR	Feb 24, 1999	Substantially Equivalent - Subject to Tracking Reg.	Cardiopulmonary Corp.
K984577	DRAGER OXYLOG 2000	Jan 22, 1999	Substantially Equivalent	Drager, Inc.
K984535	PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION	Dec 28, 1998	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K984379	NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM	Dec 10, 1998	Substantially Equivalent	Puritan Bennett Corp.
K983219	NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900	Dec 07, 1998	Substantially Equivalent	Drager, Inc.
K981412	M1145 (UPS1-1.25K-1G-MP) UPS	Nov 23, 1998	Substantially Equivalent	Clary Corp.
K983981	BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE	Nov 20, 1998	Substantially Equivalent	Bear Medical Systems, Inc.
K981072	ESPRIT VENTILATOR	Nov 12, 1998	Substantially Equivalent - Subject to Tracking Reg.	Respironics, Inc.
K981371	LTV 1000 VENTILATOR	Oct 30, 1998	Substantially Equivalent	Pulmonetic Systems, Inc.
K982580	BIRD MONITOR INTERFACE	Oct 22, 1998	Substantially Equivalent - Subject to Tracking Reg.	Bird Products Corp.
K980642	EVITA 4 (8411900)	Sep 04, 1998	Substantially Equivalent	Drager, Inc.
K981971	TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3	Aug 24, 1998	Substantially Equivalent - Subject to Tracking Reg.	Bird Products Corp.
K980208	DIVAN ANESTHESIA VENTILATOR	Aug 04, 1998	Substantially Equivalent	Draeger Medical, Inc.
K982174	VENTURI VENTILATOR	Jun 24, 1998	Substantially Equivalent - Subject to Tracking Reg.	Cardiopulmonary Corp.
K974176	BABYLOG 8000 PLUS	Jun 17, 1998	Substantially Equivalent	Drager, Inc.
K970460	NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)	Apr 30, 1998	Substantially Equivalent	Puritan Bennett Corp.
K970158	BABYPAC	Apr 28, 1998	Substantially Equivalent	Pneupac, Inc.
K964540	NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM	Nov 14, 1997	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K972203	BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT	Nov 06, 1997	Substantially Equivalent - Subject to Tracking Reg.	Allied Healthcare Products, Inc.
K970839	SERVO VENTILATOR 300A	Oct 14, 1997	Substantially Equivalent - Subject to Tracking Reg.	Siemens Elema AB
K972248	NELLCOR PURITAN BENNETT GEMINI	Sep 12, 1997	Substantially Equivalent - Subject to Tracking Reg.	Nellcor Puritan Bennett, Inc.
K970165	EVITA 2 DURA	Aug 26, 1997	Substantially Equivalent - Subject to Tracking Reg.	Drager, Inc.
K964543	INFRASONICS ADULT VENTILATOR TRENDING OPTION	Feb 14, 1997	Substantially Equivalent - Subject to Tracking Reg.	Nellcor Puritan Bennett, Inc.
K961687	EVITA 4	Dec 13, 1996	Substantially Equivalent - Subject to Tracking Reg.	Drager, Inc.
K950853	OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS	Nov 05, 1996	Substantially Equivalent - Subject to Tracking Reg.	Drager, Inc.
K960168	SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990	Oct 25, 1996	Substantially Equivalent - Subject to Tracking Reg.	Siemens Elema AB
K960010	SERVO VENTILATOR 300 COMPUTER INTERFACE	Oct 25, 1996	Substantially Equivalent - Subject to Tracking Reg.	Siemens Elema AB
K960964	OHMEDA 7900 ANESTHESIA VENTILATOR	Sep 27, 1996	Substantially Equivalent - Subject to Tracking Reg.	Ohmeda Medical
K953238	DRAGER MICRO VENT	Sep 16, 1996	Substantially Equivalent - Subject to Tracking Reg.	Drager, Inc.
K960861	OMICRON MONITOR, DELTA MONITOR	Aug 19, 1996	Substantially Equivalent - Subject to Tracking Reg.	Core-M, Inc.
K955865	BEAR CUB INFANT PRESSURE VENTILATOR	Aug 06, 1996	Substantially Equivalent - Subject to Tracking Reg.	Allied Healthcare Products, Inc.
K952880	MODEL LP-1000 VOLUME VENTILATOR	Jun 20, 1996	Substantially Equivalent - Subject to Tracking Reg.	Aequitron Medical, Inc.
K950484	TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR	May 03, 1996	Substantially Equivalent - Subject to Tracking Reg.	Bird Products Corp.
K953228	NARKOMED AV2+ ANESTHESIA VENTILATOR	Mar 01, 1996	Substantially Equivalent - Subject to Tracking Reg.	Draeger Medical, Inc.
K943106	ADULT VENTILATOR	Dec 28, 1995	Substantially Equivalent - Subject to Tracking Reg.	Infrasonics Corp.
K943412	VENTURI VENTILATOR	Oct 16, 1995	Substantially Equivalent - Subject to Tracking Reg.	Cardiopulmonary Corp.
K942938	CROSSVENT-4 VENTILATOR	Sep 19, 1995	Substantially Equivalent - Subject to Tracking Reg.	Bio-Med Devices, Inc.
K943531	OXYLOG 2000	Aug 25, 1995	Substantially Equivalent - Subject to Tracking Reg.	Drager, Inc.
K941308	NEWPORT ELECTRONIC MANOMETER	Aug 25, 1995	Substantially Equivalent - Subject to Tracking Reg.	Newport Medical Instruments, Inc.
K941309	NEWPORT ELECTRONIC MANOMETER	Mar 06, 1995	Substantially Equivalent - Subject to Tracking Reg.	Newport Medical Instruments, Inc.
K930017	PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD	Sep 22, 1994	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K924043	AUTO-PEEP	Sep 22, 1994	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K922975	MODEL 7200AE VENTILATOR (ENHANCEMENT)	Sep 22, 1994	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K922705	MODEL 7200AE VENTILATOR	Sep 22, 1994	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K922102	PROPORTIONAL SOLENOID VALVE	Sep 15, 1994	Substantially Equivalent - Subject to Tracking Reg.	Puritan Bennett Corp.
K926292	BABYLOG 8000 INFANT VENTILATOR	Apr 19, 1994	Substantially Equivalent	Drager, Inc.
K930747	BIRD 8400TI ADULT VOLUME VENTILATOR	Feb 15, 1994	Substantially Equivalent	Bird Products Corp.
K924930	EVITA	Jan 10, 1994	Substantially Equivalent	Drager, Inc.
K933262	BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903	Jul 29, 1993	Substantially Equivalent	Bird Products Corp.
K923992	POWER PACK 350/BATTERY PACK 351	Apr 13, 1993	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K921387	BIRD 8400ST ADULT VOLUME VENTILATOR	Mar 11, 1993	Substantially Equivalent	Bird Products Corp.
K923444	SERVO GRAPHICS	Mar 05, 1993	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K920113	BIRD GRAPHICS MONITOR	Feb 19, 1993	Substantially Equivalent	Bird Products Corp.
K920121	SECHRIST IV-100B SAVI SYSTEM	Feb 01, 1993	Substantially Equivalent	Sechrist
K925262	MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT	Jan 22, 1993	Substantially Equivalent	Merit Medical Systems, Inc.
K922314	VENTILATOR INTERFACE 9291/4	Dec 17, 1992	Substantially Equivalent	S & W Medico Teknik
K922654	VENTILATOR ADULT STAR MODIFICATION	Dec 01, 1992	Substantially Equivalent	Infrasonics Corp.
K920002	MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50	Nov 10, 1992	Substantially Equivalent	Puritan Bennett Corp.
K921821	IBT MODEL SVI	Nov 02, 1992	Substantially Equivalent	Biomagnetic Technologies, Inc.
K914607	SEHRIST VOLUME VENTILATOR, MODEL 2200B	Nov 02, 1992	Substantially Equivalent	Sechrist Industries, Inc.
K923809	PURITAN-BENNETT MODEL 7200AE VENTILATOR	Oct 27, 1992	Substantially Equivalent	Puritan Bennett Corp.
K923704	INFANT STAR SERIES 500	Oct 22, 1992	Substantially Equivalent	Infrasonics Corp.
K915488	PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR	Oct 22, 1992	Substantially Equivalent	Bird Products Corp.
K914424	MODEL 6213 REMOTE ALARM	Sep 10, 1992	Substantially Equivalent	Aequitron Medical, Inc.
K922477	MODEL 105 VENTILATOR, MODIFICATION	Aug 24, 1992	Substantially Equivalent	Infrasonics Corp.
K915312	MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN	Jul 08, 1992	Substantially Equivalent	Puritan Bennett Corp.
K912619	BEAR 7 VENTILATOR	Jun 11, 1992	Substantially Equivalent	Bear Medical Systems, Inc.
K911804	INFRASONICS VENTILATOR ADULT STAR, MODIFICATION	Jun 11, 1992	Substantially Equivalent	Infrasonics Corp.
K921726	HAYEK OSCILLATOR, MODIFICATION	Apr 23, 1992	Substantially Equivalent	Respironics, Inc.
K913423	LIFECARE REMOTE ALARM II	Jan 30, 1992	Substantially Equivalent	Lifecare Services, Inc.
K913972	STAR SYNC, MODIFICATION	Jan 09, 1992	Substantially Equivalent	Infrasonics Corp.
K901448	VEOLAR VENTILATOR	Dec 20, 1991	Substantially Equivalent	Hamilton Medical, Inc.
K911336	BIRD NEBULIZATION SYNCHRONIZER	Nov 29, 1991	Substantially Equivalent	Bird Products Corp.
K914485	VENTILATOR STAND	Oct 25, 1991	Substantially Equivalent	Bird Products Corp.
K912533	NARKOMED AV-E VENTILATOR	Jul 25, 1991	Substantially Equivalent	Draeger Medical, Inc.
K911450	INFANT VENTILATOR	Jun 18, 1991	Substantially Equivalent	Preemicare Corp.
K905234	TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES	Jun 13, 1991	Substantially Equivalent	Percussionaire Corp.
K903089	BABYLOG 8000 INFANT VENTILATOR	Jun 10, 1991	Substantially Equivalent	Drager, Inc.
K910847	OHMEDA 7810 ANESTHESIA VENTILATOR	May 03, 1991	Substantially Equivalent	Ohmeda Medical
K905235	VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS	May 03, 1991	Substantially Equivalent	Percussionaire Corp.
K900745	VS-200S JET VENTILATOR	Apr 29, 1991	Substantially Equivalent	Acutronic Medical Systems AG
K900744	AMS 3000 PORTABLE JET VENTILATOR	Apr 29, 1991	Substantially Equivalent	Acutronic Medical Systems AG
K902859	SERVO VENTILATOR 300	Apr 26, 1991	Substantially Equivalent	Siemens Life Support Systems
K902405	MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR	Mar 04, 1991	Substantially Equivalent	Mallinckrodt Medical
K905272	ADULT STAR, MODIFICATION	Jan 30, 1991	Substantially Equivalent	Infrasonics Corp.
K902506	7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.	Jan 08, 1991	Substantially Equivalent	Puritan Bennett Corp.
K901953	AIROX AXR. 1A	Jan 02, 1991	Substantially Equivalent	Ferguson Medical
K895513	PERRY SV-1 HYPERBARIC VENTILATOR	Dec 19, 1990	Substantially Equivalent	Perry Baromedical Services
K905244	MODEL LP6 VENTILATOR, MODIFICATION	Nov 30, 1990	Substantially Equivalent	Aequitron Medical, Inc.
K903010	CONTINUOUS VOLUME VENTILATOR MODEL LP10	Nov 30, 1990	Substantially Equivalent	Aequitron Medical, Inc.
K900315	PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN	Oct 26, 1990	Substantially Equivalent for Some Indications	Percussionaire Corp.
K900314	PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN	Oct 26, 1990	Substantially Equivalent for Some Indications	Percussionaire Corp.
K900313	PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN	Oct 26, 1990	Substantially Equivalent	Percussionaire Corp.
K902084	OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE	Oct 01, 1990	Substantially Equivalent	Ohmeda Medical
K901785	NEWPORT WAVE VENTILATOR MODEL E200	Aug 10, 1990	Substantially Equivalent	Newport Medical Instruments, Inc.
K900637	BEAR CEM CONTROLLER	Aug 03, 1990	Substantially Equivalent	Bear Medical Systems, Inc.
K900465	MAX TRANSPORT VENTILATOR	Jun 18, 1990	Substantially Equivalent	Hamilton Medical, Inc.
K896269	SECHRIST VOLUME VENTILATOR MODEL 2200B	May 18, 1990	Substantially Equivalent	Sechrist Industries, Inc.
K896442	PPG BIOMEDICAL VENTILATOR MODEL IRISA	Apr 16, 1990	Substantially Equivalent	Ppg Industries, Inc.
K897113	PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR	Mar 26, 1990	Substantially Equivalent	Puritan Bennett Corp.
K884389	MODIFIED 225/SIMV VOLUME VENTILATOR	Mar 12, 1990	Substantially Equivalent	Monaghan Medical Corp.
K895541	V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR	Mar 08, 1990	Substantially Equivalent	Bird Products Corp.
K896736	TYPE 9291 INTERFACE RESPIRATOR	Feb 28, 1990	Substantially Equivalent	S & W Medico Teknik
K896735	TYPE 9290 INTERFACE RESPIRATOR	Feb 28, 1990	Substantially Equivalent	S & W Medico Teknik
K896381	MVP-10 MRI INFANT VENTILATOR	Feb 12, 1990	Substantially Equivalent	Bio-Med Devices, Inc.
K896380	IC-2A MRI ADULT/PEDIATRIC VENTILATOR	Feb 12, 1990	Substantially Equivalent	Bio-Med Devices, Inc.
K894322	8400ST VOLUME VENTILATOR	Jan 29, 1990	Substantially Equivalent	Bird Products Corp.
K893622	PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.	Jan 03, 1990	Substantially Equivalent	Preemicare Corp.
K895779	MODIFIED PERMCATH TRAY (2ND SUBMISSION)	Dec 07, 1989	Substantially Equivalent	Quinton, Inc.
K892886	PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR	Oct 27, 1989	Substantially Equivalent	Percussionaire Corp.
K895486	BIRD (VDR) SINUSOIDAL PERCUSSIONATORS	Oct 13, 1989	Substantially Equivalent	Percussionaire Corp.
K894426	LEONARDO INFORMATION SYSTEM	Sep 26, 1989	Substantially Equivalent	Hamilton Medical, Inc.
K894316	AMADEUS VENTILATOR	Sep 22, 1989	Substantially Equivalent	Hamilton Medical, Inc.
K893786	SERVO ANESTHESIA CIRCLE 985	Sep 22, 1989	Substantially Equivalent	Siemens Life Support Systems
K884832	PERCUSSIONAIRE RESPIRATORS (MULTIPLE)	Sep 14, 1989	Substantially Equivalent	Percussionaire Corp.
K893043	PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR	Aug 04, 1989	Substantially Equivalent	Puritan Bennett Corp.
K883809	NEWPORT VENTILATOR MODEL E150	Jun 23, 1989	Substantially Equivalent	Newport Medical Instruments, Inc.
K884793	ADVENT VENTILATOR	Jun 12, 1989	Substantially Equivalent	Ohmeda Medical
K890921	DATA EXCHANGE SYSTEM, MODEL 24	Jun 08, 1989	Substantially Equivalent	Siemens Life Support Systems
K884521	STAR SYNC	Jun 08, 1989	Substantially Equivalent	Infrasonics Corp.
K883865	EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010	Jun 08, 1989	Substantially Equivalent	Acutronic Medical Systems AG
K883159	OHMEDA 7800 ANESTHESIA VENTILATOR	Jun 06, 1989	Substantially Equivalent	Ohmeda Medical
K884520	SERVO VENTILATOR 900E	Jan 17, 1989	Substantially Equivalent	Siemens-Elema Ventilation Systems
K882764	BEAR EVC-100 CONTROLLER	Sep 30, 1988	Substantially Equivalent	Bear Medical Systems, Inc.
K880923	PATIENT VENTILATOR ISOLATOR	Sep 06, 1988	Substantially Equivalent	Dryden Corp.
K881335	BEAR 3 VENTILATOR	Aug 04, 1988	Substantially Equivalent	Bear Medical Systems, Inc.
K872466	ADULT STAR	Jul 08, 1988	Substantially Equivalent	Infrasonics Corp.
K881482	VEOLAR VENTILATOR	Jun 16, 1988	Substantially Equivalent	Hamilton Medical, Inc.
K881420	OMNI-VENT, SERIES D/MRI	Jun 14, 1988	Substantially Equivalent	Stein-Gates Medical Equipment, Inc.
K873151	MODEL 7200A, PRESSURE VENTILATION OPTION	May 31, 1988	Substantially Equivalent	Puritan Bennett Corp.
K871792	VEOLAR VENTILATOR	Apr 21, 1988	Substantially Equivalent	Hamilton Medical, Inc.
K880721	6400ST INTERFACE MODULE-RS232	Apr 14, 1988	Substantially Equivalent	Bird Products Corp.
K880054	CPU 1100 VENTILATOR	Apr 14, 1988	Substantially Equivalent	Ohmeda Medical
K872113	OMNI-VENT, SERIES D	Mar 23, 1988	Substantially Equivalent	Stein-Gates Medical Equipment, Inc.
K872482	GAMBRO-ENGSTROM ERICA IV RESPIRATOR	Mar 03, 1988	Substantially Equivalent	Gambro, Inc.
K873215	COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION	Jan 22, 1988	Substantially Equivalent	Puritan Bennett Corp.
K870861	UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR	Jan 19, 1988	Substantially Equivalent	Impact Instrumentation, Inc.
K874415	PRESSURE LIMIT CONTROL	Jan 11, 1988	Substantially Equivalent	Draeger Medical, Inc.
K874371	ASCENDING VENTILATOR BELLOWS	Dec 11, 1987	Substantially Equivalent	Draeger Medical, Inc.
K873549	PEDIATRIC BELLOWS	Oct 08, 1987	Substantially Equivalent	Draeger Medical, Inc.
K863155	UNIVERSAL JET VENTILATOR MODEL AMS-1000	Sep 28, 1987	Substantially Equivalent	Acutronic Medical Systems AG
K871354	SERVO VENTILATOR 900 C/D	Jul 21, 1987	Substantially Equivalent	Siemens Elema AB
K871985	BEAR JET VENTILATOR FOR USE DURING (ESWL)	Jun 15, 1987	Substantially Equivalent	Bear Medical Systems, Inc.
K871433	PPG BIOMEDICAL VENTILATOR MODEL AV 400	May 29, 1987	Substantially Equivalent	Ppg Industries, Inc.
K871448	MODEL 105 VENTILATOR	May 07, 1987	Substantially Equivalent	Developmed Corp.
K871398	CPU-1 INTENSIVE CARE VENTILATOR	May 07, 1987	Substantially Equivalent	Ohmeda Medical
K871009	MVP-1500 CONTINUOUS VENTILATOR	May 06, 1987	Substantially Equivalent	Medimex, Inc.
K870275	COMPANION 2800 PORTABLE VOLUME VENTILATOR	Mar 09, 1987	Substantially Equivalent	Puritan Bennett Corp.
K863228	BIRD 6400ST VOLUME VENTILATOR	Feb 10, 1987	Substantially Equivalent	Bird Products Corp.
K864431	PEDIATRIC BELLOWS	Jan 12, 1987	Substantially Equivalent	Draeger Medical, Inc.
K864129	OHMEDA 7400 ANESTHESIA VENTILATOR	Dec 16, 1986	Substantially Equivalent	Ohmeda Medical
K864379	EMERSON 3MV VOLUME VENTILATOR	Dec 15, 1986	Substantially Equivalent	J. H. Emerson Co.
K864105	LUNG MECHANICS SOFTWARE PROGRAM	Nov 07, 1986	Substantially Equivalent	Siemens Elema AB
K863546	CPU GRAPH	Sep 18, 1986	Substantially Equivalent	Ohmeda Medical
K862712	EMERSON MODEL 3HV COMPACT VENTILATOR	Sep 18, 1986	Substantially Equivalent	J. H. Emerson Co.
K862810	COMPANION 2500 PORTABLE VOLUME VENTILATOR	Sep 15, 1986	Substantially Equivalent	Puritan Bennett Corp.
K862604	7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT	Aug 01, 1986	Substantially Equivalent	Puritan Bennett Corp.
K860798	ARF-1500 CONTINUOUS VENTILATOR	Jul 10, 1986	Substantially Equivalent	Medimex, Inc.
K862212	LIFECARE REMOTE ALARM #34-001	Jun 23, 1986	Substantially Equivalent	Lifecare Services, Inc.
K861707	MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR	Jun 19, 1986	Substantially Equivalent	Siemens Elema AB
K862025	ENGSTROM ERICA II RESPIRATOR	Jun 18, 1986	Substantially Equivalent	Gambro, Inc.
K861488	COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM	May 06, 1986	Substantially Equivalent	Puritan Bennett Corp.
K861432	VEOLAR VENTILATOR	May 06, 1986	Substantially Equivalent	Hamilton Medical, Inc.
K860438	NEWPORT VENTILATOR MODEL E-100	May 06, 1986	Substantially Equivalent	Newport Medical Instruments, Inc.
K860675	COMPANION 2800 VOLUME VENTILATOR REMOT ALARM	Apr 07, 1986	Substantially Equivalent	Puritan Bennett Corp.
K853501	HONEYWELL ELECTRONIC VENTILATOR EV-A	Apr 04, 1986	Substantially Equivalent	Honeywell, Inc.
K854070	MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM	Feb 14, 1986	Substantially Equivalent	Puritan Bennett Corp.
K854300	7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY	Jan 21, 1986	Substantially Equivalent	Puritan Bennett Corp.
K853760	ADULT VENTILATOR TESTER VT-1	Dec 03, 1985	Substantially Equivalent	Bio-Tek Instruments, Inc.
K852771	PC INTERFACE	Oct 10, 1985	Substantially Equivalent	Siemens Elema AB
K853300	HEALTHDYNE IMPLUSE VENTILATOR	Aug 15, 1985	Substantially Equivalent	Healthdyne, Inc.
K851509	OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR	Jul 15, 1985	Substantially Equivalent	Ohmeda Medical
K850374	CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO	Apr 25, 1985	Substantially Equivalent	Siemens Elema AB
K844179	LP-5	Jan 18, 1985	Substantially Equivalent	Life Products, Inc.
K842122	4A	Jan 18, 1985	Substantially Equivalent	Life Products, Inc.
K844081	LP4 VENTILATOR	Jan 16, 1985	Substantially Equivalent	Life Products, Inc.
K844912	SERVO VENTILATOR 900D SIEMENS-ELEMA AB	Dec 28, 1984	Substantially Equivalent	Siemens Elema AB
K844350	NEWPORT VENTILATOR MODEL E-100	Dec 27, 1984	Substantially Equivalent	Newport Medical Instruments, Inc.
K844590	POWER PACK 160 SIEMENS-ELEMA AB	Nov 29, 1984	Substantially Equivalent	Siemens Elema AB
K843424	MICROPROCESSOR 7200A VENTILATOR	Nov 01, 1984	Substantially Equivalent	Puritan Bennett Corp.
K843737	PNEUPAC INSTANT ACTION VENTILATOR/RESUS	Oct 04, 1984	Substantially Equivalent	Pneupac , Ltd.
K842876	PORTABLE LIFECARE VENTILATOR PLV-102	Aug 29, 1984	Substantially Equivalent	Lifecare Services, Inc.
K842688	BEAR JET-150 VENTILATOR	Jul 26, 1984	Substantially Equivalent	Bear Medical Systems, Inc.
K842363	PENLON ANESTHESIA VENTILATOR SERIES 300	Jun 26, 1984	Substantially Equivalent	Bear Medical Systems, Inc.
K842362	PENLON TRANSPORT VENTILATOR SERIES 350	Jun 26, 1984	Substantially Equivalent	Bear Medical Systems, Inc.
K841818	IMPULSE VENTILATOR	Jun 05, 1984	Substantially Equivalent	Healthdyne, Inc.
K841529	SIEMENS-ELEMA VENTILATOR 900C	May 23, 1984	Substantially Equivalent	Siemens Elema AB
K841279	BEAR 33	May 23, 1984	Substantially Equivalent	Bear Medical Systems, Inc.
K841393	AB MANUAL VENTILATION ACCESS. 900C	May 21, 1984	Substantially Equivalent	Siemens Elema AB
K841757	7200 MICROPROCESSOR VENTILATOR	May 16, 1984	Substantially Equivalent	Puritan Bennett Corp.
K840865	INFANT STAR VENTILATOR	Apr 30, 1984	Substantially Equivalent	Infrasonics Corp.
K840119	CONTINUOUS VENTILATOR	Apr 06, 1984	Substantially Equivalent	Bear Medical Systems, Inc.
K833982	MODEL IV 100B-DA INFANT VENTILATOR	Mar 05, 1984	Substantially Equivalent	Sechrist Industries, Inc.
K840345	IMPULSE VENTILATOR	Feb 23, 1984	Substantially Equivalent	Healthdyne, Inc.
K832508	VOLUME VENTILATOR	Dec 27, 1983	Substantially Equivalent	Sechrist Industries, Inc.
K833786	MICROPROCESSOR VENTILATOR 7200	Dec 22, 1983	Substantially Equivalent	Puritan Bennett Corp.
K832700	PNEU PAC VENTILATOR/RESUSCITATORS	Nov 14, 1983	Substantially Equivalent	Pneupac , Ltd.
K831877	ARF 850 E	Nov 03, 1983	Substantially Equivalent	W.E. Leder Enterprises, Inc.
K832467	PORTABLE LIFECARE VENTILATOR PLV-100	Oct 20, 1983	Substantially Equivalent	Lifecare Services, Inc.
K822835	PZ-800 VOLUME VENTILATOR	Sep 29, 1983	Substantially Equivalent	Narco Scientific
K830488	VENTILATOR #1	Sep 15, 1983	Substantially Equivalent	Ohio Medical Products
K830230	PROGRAMMABLE VENTILATOR	Feb 09, 1983	Substantially Equivalent	Bio-Med Devices, Inc.
K823861	ET-3 EMERGENCY TRANSPORT VENTILATOR	Feb 07, 1983	Substantially Equivalent	Bio-Med Devices, Inc.
K823858	VOLUME VENTILATOR	Dec 22, 1982	Substantially Equivalent	Puritan Bennett Corp.
K822888	OHIO CPU-1 INTENSIVE CARE VENTILATOR	Nov 16, 1982	Substantially Equivalent	Ohio Medical Products
K822635	225 S.I.M.V. VENTILATOR	Nov 16, 1982	Substantially Equivalent	Monaghan Medical Corp.
K822456	OHIO V5A ANESTHESIA VENTILATOR	Sep 21, 1982	Substantially Equivalent	Airco/Ohio Medical Products
K822113	INSPIRAID VA-1 VENTILATOR	Aug 31, 1982	Substantially Equivalent	Inspir Aid
K822233	ABT 4000 VENTILATOR	Aug 27, 1982	Substantially Equivalent	Kontron Instruments, Inc.
K822040	POWERED EMERGENCY VENTILATOR	Aug 19, 1982	Substantially Equivalent	Fraser Harlake, Inc.
K821930	SECHRIST MODEL 990 JET VENTILATOR	Aug 16, 1982	Substantially Equivalent	Sechrist Industries, Inc.
K821792	NEUMOVENT 980	Aug 02, 1982	Substantially Equivalent	Ultramar Marketing Corp.
K822103	MODEL M3000XA VENTILATOR SPECIFICA	Jul 26, 1982	Substantially Equivalent	Thompson Respiration Products, Inc.
K821376	OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.	Jun 29, 1982	Substantially Equivalent	Ohio Medical Products
K820746	NEWPORT VENTILATOR MODEL E100	Apr 16, 1982	Substantially Equivalent	Newport Medical Instruments, Inc.
K820248	RODDER VOLUME VENTILATOR	Apr 16, 1982	Substantially Equivalent	Pharmaquest Corp.
K812961	SHEFFIELD INFANT VENTILATOR MARK 4	Mar 26, 1982	Substantially Equivalent	Cairco , Ltd.
K820393	ANESTHESIA VENTILATOR	Mar 12, 1982	Substantially Equivalent	Puritan Bennett Corp.
K820220	VENTILATOR MODELS	Feb 18, 1982	Substantially Equivalent	Pneupac , Ltd.
K813254	JET VENTILATOR	Feb 04, 1982	Substantially Equivalent	Healthdyne, Inc.
K820132	BABYBIRD 2 VENTILATOR	Jan 28, 1982	Substantially Equivalent	3M Company
K812958	EAST-FREEMAN VENTILATOR MARK 2	Jan 07, 1982	Substantially Equivalent	Cairco , Ltd.
K812016	VS600 JET VENTILATOR	Dec 30, 1981	Substantially Equivalent	Instrument Development Corp.
K813253	IC-5 VENTILATOR	Dec 09, 1981	Substantially Equivalent	Bio-Med Devices, Inc.
K812953	RADCLIFFE VENTILATOR MARK 5	Nov 27, 1981	Substantially Equivalent	Cairco , Ltd.
K812980	MA-2 VENTILATOR	Nov 06, 1981	Substantially Equivalent	Bio-Medical Repair, Inc.
K812642	ENGSTROM ERICA	Nov 05, 1981	Substantially Equivalent	Lkb Instruments, Inc.
K810893	HEWLETT-PACKARD VENTILATOR	Jun 18, 1981	Substantially Equivalent	Hewlett-Packard Co.
K811141	SECHRIST INFANT VENTRILATOR MODEL IV-100	Jun 12, 1981	Substantially Equivalent	Sechrist Industries, Inc.
K811102	SIEMENS-ELEMA AB SERVO VENTILATOR 900 C	May 05, 1981	Substantially Equivalent	Siemens Elema AB
K802168	DRAGER AV2 ANESTHESIA VENTILATOR	Dec 20, 1980	Substantially Equivalent	Draeger Medical, Inc.
K802583	INFANT VENTILATOR, (RESPIRATOR) PLAN B	Dec 18, 1980	Substantially Equivalent	Healthdyne, Inc.
K801890	IC-2 VENTILATOR	Nov 18, 1980	Substantially Equivalent	Bio-Med Devices, Inc.
K802270	PROTECTIVE BAR FOR THE MA-1VENTILATOR	Oct 03, 1980	Substantially Equivalent	Eastern Anesthesia, Inc.
K802118	BEAR 2 ADULT VOL. VENTILATOR	Oct 03, 1980	Substantially Equivalent	Bourns Medical Systems, Inc.
K802087	BABYBIRD 2 VENTILATOR	Oct 03, 1980	Substantially Equivalent	Bird Products Corp.
K802051	NEWBOURNS INFANT VENTILATOR	Oct 03, 1980	Substantially Equivalent	Bourns Medical Systems, Inc.
K801697	MODEL BP-200 INFANT PRESSURE VENTILATOR	Aug 07, 1980	Substantially Equivalent	Bourns Medical Systems, Inc.
K800999	CAM-10 EXSUFFLATION BELT #11-001	May 28, 1980	Substantially Equivalent	Lifecare Services, Inc.
K800650	MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM	Apr 02, 1980	Substantially Equivalent	Hospal Medical Corp.
K800114	SIEMENS-ELEMA AB MANUAL VENTILATION	Mar 05, 1980	Substantially Equivalent	Siemens Elema AB
K792459	PNEUPAC VENTILATOR/RESUSCITATOR	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K792456	PNEUPAC VENTILATOR/RESUSCITATOR #3	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K792455	PNEUPAC VENTILATOR/RESUSCITATOR #2	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K800125	VENTILATOR TEST LUNG	Jan 24, 1980	Substantially Equivalent	Bio-Med Devices, Inc.
K792564	MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR	Dec 19, 1979	Substantially Equivalent	Eastern Anesthesia, Inc.
K791713	VICKERS MEDICAL MODEL 130 NEAVENT-NEO	Sep 19, 1979	Substantially Equivalent	Vickers America Medical Corp.
K791186	MODEL BP-2000 TIME-CYCLED VENTILATOR	Jul 06, 1979	Substantially Equivalent	Bourns Medical Systems, Inc.
K791188	CAM-10 BATTERY PACK (#7-001)	Jul 05, 1979	Substantially Equivalent	Lifecare Services, Inc.
K791033	CAM-10 PVV PORTABLE VOLUME VENTILATOR	Jul 03, 1979	Substantially Equivalent	Lifecare Services, Inc.
K790605	RESPIRAOTR, CAM-10 RBL	Jul 03, 1979	Substantially Equivalent	Lifecare Services, Inc.
K790809	VS, ANESTHESIA VENTILATOR	May 04, 1979	Substantially Equivalent	Airco/Ohio Medical Products
K790733	VENTIMETER VENTILATOR	Apr 19, 1979	Substantially Equivalent	Narco Air-Shields
K790732	VENTIMETER CONTROLLER	Apr 19, 1979	Substantially Equivalent	Narco Air-Shields
K790199	VENTILATOR MODEL BV-300 INFANT	Apr 13, 1979	Substantially Equivalent	Bourns Medical Systems, Inc.
K782074	VENTILATOR, MODEL AVA-1, ADULT	Dec 21, 1978	Substantially Equivalent	Rule Medical Instruments, Inc.
K781926	VENTILATOR, INFANT MODEL 100	Dec 21, 1978	Substantially Equivalent	Healthdyne, Inc.
K781160	VENTILATOR, MINILUNG	Dec 13, 1978	Substantially Equivalent	Thompson Respiration Products, Inc.
K781159	VENTILATOR, PRESSURE	Dec 12, 1978	Substantially Equivalent	Thompson Respiration Products, Inc.
K781161	RESPIRATOR, BANTAM MODEL	Dec 11, 1978	Substantially Equivalent	Thompson Respiration Products, Inc.
K780188	INFANT VENTILATOR MODEL 100	Apr 10, 1978	Substantially Equivalent	Sechrist Industries, Inc.
K772065	CRITICAL CARE VENTILATOR 2	Nov 28, 1977	Substantially Equivalent	Ohio Medical Products
K771039	RESPIRATOR, PROTABLE, VOLUME CONTROLLED	Aug 05, 1977	Substantially Equivalent	Dept. of the Navy
K770132	MODEL LP-3 PORTABLE VOLUME VENTILATOR	Feb 01, 1977	Substantially Equivalent	Life Products, Inc.
K760663	MVP-10 PEDIATRIC/NEONATAL VENTILATOR	Sep 27, 1976	Substantially Equivalent	Air-Shields, Inc.