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 |
K182956 |
International Biomedical |
Puffin Lite Infant Resuscitation System |
01/18/2019 |
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 |
K141595 |
O-TWO MEDICAL TECHNOLOGIES, INC. |
O-TWO E700,O-TWO E600,O-TWO E500 |
03/16/2015 |
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 |
K161420 |
THORNHILL RESEARCH INC. |
MOVES SLC |
06/06/2017 |
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 |
K162968 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
VORTRAN GO2VENT |
04/10/2017 |