FDA 510(k) Applications for Medical Device Product Code "BTL"
(Ventilator, Emergency, Powered (Resuscitator))

FDA 510(k) Number Applicant Device Name Decision Date
K080692 AIRON CORPORATION MACS CPAP SYSTEM 06/20/2008
K132021 ALLIED HEALTHCARE PRODUCTS, INC. AHP 300, EMERGENCY PORTABLE VENTILATOR 04/02/2014
K070636 ALLIED HEALTHCARE PRODUCTS, INC. AUTOVENT 4000 WITH CPAP 07/13/2007
K070120 ALLIED HEALTHCARE PRODUCTS, INC. AUTOVENT MODEL 4000 05/03/2007
K083507 ALLIED HEALTHCARE PRODUCTS, INC. BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS 05/18/2009
K131098 ALLIED HEALTHCARE PRODUCTS, INC. EMERGENCY PORTABLE VENTILATOR 04/09/2014
K090356 ALLIED HEALTHCARE PRODUCTS, INC. EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 05/20/2009
K080063 ALLIED HEALTHCARE PRODUCTS, INC. MASS CASUALTY VENTILATOR, MODEL MCV100 08/15/2008
K083385 ALLIED HEALTHCARE PRODUCTS, INC. MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B 05/14/2009
K072214 ALLIED HEALTHCARE PRODUCTS, INC. PORTABLE VENTILATOR, MODEL EPV-100 03/06/2008
K904920 AMBU, INC. AMBU MATIC AUTOMATIC RESUSCITATOR 05/28/1991
K921926 ANESTHESIA ASSOC., INC. JET VENTILATOR/JETTING DEVICE 10/13/1992
K102542 ATOM MEDICAL CORPORATION RESUSCI FLOW; RESUSCI FLOW 104 04/06/2011
K131877 AUTOMEDX INC. SAVE II, SAVE II BASIC 03/21/2014
K071221 AUTOMEDX INC. SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 09/06/2007
K895946 BIVONA MEDICAL TECHNOLOGIES BIVONA CARDEN INTERMITTENT JETTING DEVICE 01/09/1990
K944349 CPR MEDICAL DEVICES, INC. OXYLATOR EM-100 04/17/1995
K841893 CRYO2 CORP. MAXAMAN 08/30/1984
K132759 DOLPHYS MEDICAL B.V. VENTRAIN 03/26/2014
K951126 DRAGER, INC. DRAGER MEDICAL AIR COMPRESSOR 03/24/1995
K021520 EMERGENCY MEDICAL TECHOLOGY EMT-CPAP 07/15/2002
K892885 FISHER & PAYKEL ELECTRONICS LTD. RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR 10/06/1989
K771299 FRASER SWEATMAN, INC. EMERGENCY OXYGEN RESUSCITATOR 08/04/1977
K882833 HURSCH ENT., INC. THE BERG RESUSCITATION APPARATUS 08/19/1988
K931473 IMPACT INSTRUMENTATION, INC. IMPACT MODEL 753 12/30/1994
K861272 IMPACT INSTRUMENTATION, INC. IMPACT MODELS 701, 702 AND 703 05/20/1986
K905697 IMPACT INSTRUMENTATION, INC. POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE 12/27/1990
K032386 IMPACT INSTRUMENTATION, INC. UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) 03/26/2004
K051476 IMPACT INSTRUMENTATION, INC. UNI-VENT MODEL 73X 10/28/2005
K991785 INSTRUMENTATION INDUSTRIES, INC. MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR 08/17/1999
K860077 INSTRUMENTATION INDUSTRIES, INC. SG-066 OXYGEN ENRICHMENT KIT 02/18/1986
K140707 INTERNATIONAL BIOMEDICAL LIFEBORNE INFANT RESUSCITATOR 05/28/2014
K920910 J. H. EMERSON CO. OXYGEN POWERED RESUSCITATOR FOR CPR 01/12/1993
K800456 KHI, INC. EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR. 03/18/1980
K830404 KHI, INC. RAD VALVE 03/17/1983
K855092 LIFE CORP. LIFE CORP. OXYGEN PAC 01/21/1986
K910201 LIFE CORP. LIFE O2 02/01/1991
K910435 LIFE CORP. LIFE OXYGENPAC 6/12 LPM 06/17/1991
K910434 LIFE CORP. LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL 06/17/1991
K910699 LIFE CORP. LIFE-02 (NON-REFILLABLE CYLINDER) 06/18/1991
K851337 LIFE SUPPORT PRODUCTS, INC. 502 RESUSCITATORY INHALATOR VALVE 05/15/1985
K874656 LIFE SUPPORT PRODUCTS, INC. AUTOMATIC VENTILATOR AV2000 01/19/1988
K870424 LIFE SUPPORT PRODUCTS, INC. LSP AUTOMATIC VENTILATOR, MODEL 456 01/22/1988
K932200 LIFE SUPPORT PRODUCTS, INC. LSPI AUTOMATIC VENTILATOR 11/24/1993
K941870 LIFE SUPPORT PRODUCTS, INC. LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 01/09/1995
K932199 LIFE SUPPORT PRODUCTS, INC. LSPI AUTOMATIC VENTILATOR, MODEL AV3000 11/24/1993
K941871 LIFE SUPPORT PRODUCTS, INC. LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 01/09/1995
K915564 LIFE SUPPORT PRODUCTS, INC. SPIROS 01/30/1992
K924272 MEDFLOW CORP., INC. MEDIRESP III 02/09/1994
K142096 MERCURY MEDICAL T-PIECE RESUSCITATOR 10/17/2014
K093913 MERCURY MEDICAL, INC. MERCURY MEDICAL T-PIECE RESUSCITATOR 04/06/2010
K092085 NEOFORCE GROUP, INC. ISPIRA RESUSCITATION UNIT 10/07/2009
K884089 NEOTRONICS MEDICAL LTD. ERA 2000 EMERGENCY RESUSCITATOR 12/20/1988
K911261 NEOTRONICS, INC. ERA 2000A 05/31/1991
K051469 O-TWO MEDICAL TECHNOLOGIES, INC. CAREVENT ATV+ AND CAREVENT MRI 09/28/2005
K051889 O-TWO MEDICAL TECHNOLOGIES, INC. CAREVENT CA AND DRA 08/30/2005
K093862 O-TWO MEDICAL TECHNOLOGIES, INC. CAREVENT HANDHELD CPAP SYSTEM 05/06/2010
K081330 O-TWO MEDICAL TECHNOLOGIES, INC. CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) 03/06/2009
K983785 O-TWO SYSTEMS INTL., INC. AUTOVENT 1000 10/29/1998
K983857 O-TWO SYSTEMS INTL., INC. AUTOVENT 1500 11/04/1998
K991195 O-TWO SYSTEMS INTL., INC. CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV 04/22/1999
K983705 O-TWO SYSTEMS INTL., INC. EMT RESUSCITATOR 10/29/1998
K913039 O-TWO SYSTEMS INTL., INC. FLLYNN(R) GENESIS AC 08/25/1992
K932170 O-TWO SYSTEMS INTL., INC. FLYNNR GENESIS II A/C, A/O AND IDLH 10/25/1993
K983643 O-TWO SYSTEMS INTL., INC. GENESIS BLS 10/29/1998
K070210 OHMEDA MEDICAL GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM 04/20/2007
K901846 OHMEDA MEDICAL OHMEDA - LOGIC 07A TRANSPORT VENTILATOR 08/08/1990
K021841 PNEU PAC, LTD. COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER 07/17/2003
K862830 PNEU PAC, LTD. MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR 10/15/1986
K960515 PNEU PAC, LTD. PARAPAC 10/10/1996
K020899 PNEU PAC, LTD. PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D 12/13/2002
K030803 PNEU PAC, LTD. PARAPAC 200D TRANSPORT, MODEL V200D 09/29/2003
K863410 PNEU PAC, LTD. PATIENT VALVE WITH AIR ENTRAINMENT 01/12/1987
K792453 PNEU PAC, LTD. PNEUPAC OXYGEN THERAPY UNIT 02/05/1980
K040090 PNEUPAC LTD. COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) 05/27/2004
K780168 POHLMANN RESCUE PRODUCTS, INC. PARAMEDIC O2 KIT 04/18/1978
K944397 RACAL HEALTH & SAFETY, INC. BNOS MICROVENT, MODEL AC AND MODEL AO 01/31/1995
K123957 SMITHS MEDICAL INTERNATIONAL LTD. PNEUPAC PARAPAC PLUS 09/16/2013
K043495 SMITHS MEDICAL INTERNATIONAL LTD., LUTON BABYPAC 04/22/2005
K071527 SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC VR1 AIR MIX 10/04/2007
K051322 SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS 08/05/2005
K982225 SPIRACLE TECHNOLOGY SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 10/28/1998
K853971 STEPHENSON INDUSTRIES, INC. REGULATOR-INHALATOR SYSTEM 12/09/1985
K093261 THORNHILL RESEARCH INC MOVES 03/26/2010
K140049 THORNHILL RESEARCH INC MOVES SLC 05/29/2014
K862192 U.O. EQUIPMENT CO. RESUSCITATOR MODELS 10400/10500/10600/10700/10800 07/07/1986
K112783 VBM MEDIZINTECHNIK GMBH MANUJET III 12/22/2011
K001430 VORTRAN MEDICAL TECHNOLOGY 1, INC. RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 07/05/2000
K973975 VORTRAN MEDICAL TECHNOLOGY 1, INC. RESPIRTECHPRO 06/12/1998
K073261 VORTRAN MEDICAL TECHNOLOGY 1, INC. VAR MONITOR 05/23/2008
K041473 VORTRAN MEDICAL TECHNOLOGY 1, INC. VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM 07/15/2004


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