FDA 510(k) Applications for Medical Device Product Code "CAP"
(Monitor, Airway Pressure (Includes Gauge And/Or Alarm))

FDA 510(k) Number Applicant Device Name Decision Date
K812140 3M COMPANY BIRD MEAN AIRWAY PRESSURE MONITOR 08/20/1981
K102377 A PLUS MEDICAL VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 11/18/2010
K936009 ACUTRONIC MEDICAL SYSTEMS AG AMS 3000M 05/03/1995
K040991 AMBU, INC. AMBU DISPOSABLE PRESSURE MANOMETER 07/22/2004
K140370 BESMED HEALTH BUSINESS CORP. DISPOSABLE PRESSURE MANOMETER 06/19/2014
K871336 BIO-MED DEVICES, INC. M-1 PRESSURE MONITOR 06/05/1987
K871139 BIO-MED DEVICES, INC. M-10 VENTILATION MONITOR 04/21/1987
K802565 BIRD PRODUCTS CORP. 3MP-7 SCANNER RESPIRATORY MONITOR 10/31/1980
K810547 BUNNELL LIFE SYSTEMS, INC. BLSI VENTILATION MONITOR 03/11/1981
K812960 CAIRCO LTD. EAST VENTILARM PRESSURE MONITOR ALARM S. 11/16/1981
K925673 CANADIAN MONAGHAN LTD. AIRWAY PRESSURE MONITOR CM 5000 NGAN 06/09/1993
K871083 CANADIAN MONAGHAN LTD. CM 5000 MONITOR AIRWAY PRESSURE 04/08/1987
K873953 CANADIAN MONAGHAN LTD. CM 5000R REMOTE AIRWAY PRESSURE 10/27/1987
K931394 CANADIAN MONAGHAN LTD. CM5000R REMOTE INDICATOR 07/01/1993
K931287 CANADIAN MONAGHAN LTD. CM7000 REMOTE INDICATOR 07/01/1993
K992101 CARADYNE, LTD. CRITERION 40 OR PM 40 01/06/2000
K000959 CARADYNE, LTD. CRITERION 60 OR PM 60 06/22/2000
K892942 CORE-M, INC. BREATH TRACKER 06/23/1989
K921978 CORE-M, INC. BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE 11/17/1992
K840279 DRAEGER MEDICAL, INC. DRAGER BAROMED 03/02/1984
K802090 DRAEGER MEDICAL, INC. DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC 09/26/1980
K861720 DRAEGER MEDICAL, INC. MODIFIED BAROMED BREATHING PRESSURE MONITOR 05/09/1986
K003497 ENGINEERED MEDICAL SYSTEMS DISPOSABLE PRESSURE MONITOR 11/30/2000
K852826 FERGUSON MEDICAL AN PRESSURE MONITOR 12/03/1985
K852824 FERGUSON MEDICAL PMA PRESSURE MONITOR 12/03/1985
K820353 FLORIDA MEDICAL EQUIPMENT REPAIR, INC. MONITRON MODEL JL-7 03/12/1982
K122627 GALEMED CORP. GIO DIGITAL PRESSURE GUAGES 08/22/2013
K810255 HEALTHDYNE, INC. MEAN PRESSURE MONITOR 02/12/1981
K896136 HUDSON OXYGEN THERAPY SALES CO. INFANT C.P.A.P. MONITOR 01/09/1990
K895747 HUDSON OXYGEN THERAPY SALES CO. VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR 10/27/1989
K810753 IMPACT INSTRUMENTATION, INC. AIRWAY PRESSURE MONITOR 03/31/1981
K081778 INSTRUMENTATION INDUSTRIES, INC. NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS 09/12/2008
K792515 INTERSECT MEDICAL PRODUCTS, INC. RESPIRATOR DISCONNECT ALARM 01/09/1980
K792516 INTERSECT MEDICAL PRODUCTS, INC. RESPIRATOR DISCONNECT ALARM CR 201 01/09/1980
K791527 INTERSECT MEDICAL PRODUCTS, INC. RESPIRATOR DISCONNECT ALARM CR201 09/19/1979
K791561 INTERSECT MEDICAL PRODUCTS, INC. RESPIRATOR DISCONNECT ALARM VA-100 09/19/1979
K122077 INTERSURGICAL, INC. MANOMETER 01/10/2013
K961318 INTERTECH RESOURCES, INC. 1ST RESPONSE DISPOSABLE MANOMETER 12/17/1996
K832271 J. H. EMERSON CO. EMERSON MODEL 3MV-AP AND 3V-AP PRESS- 09/12/1983
K851905 LIFE PRODUCTS, INC. LPA-2 REMOTE ALARM 07/08/1985
K894361 LIFECARE SERVICES, INC. LIFECARE PRESSURE ALARM CAT. NO. 34-010 10/05/1989
K812041 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. VENTI-MONITOR MODEL 101 09/25/1981
K954486 MERCURY MEDICAL MERCURY AIRWAY PRESSURE MANOMETER 04/25/1996
K940375 MICRO DIRECT, INC. MICRO MPM 11/21/1994
K821649 MONAGHAN MEDICAL CORP. MONAGHAN'S PRESSURE ALARM 08/05/1982
K110119 NEOFORCE GROUP INC PRESSURE MANOMETER 06/10/2011
K802955 NOVAMETRIX MEDICAL SYSTEMS, INC. MONITOR, AIRWAY PRESSURE 12/19/1980
K781714 NOVAMETRIX MEDICAL SYSTEMS, INC. PNEUMOGARD MODEL 1230 11/27/1978
K864536 OHMEDA MEDICAL OHMEDA 5500 AIRWAY PRESSURE MONITOR 01/12/1987
K801254 PENLON, INC. PENLON I.D.P. PRESSSURE FAILURE ALARM 06/09/1980
K894689 PENLON, INC. PENLON IDP PRESSURE FAILURE ALARM 08/10/1989
K840420 RESPIRATORY SUPPORT PRODUCTS, INC. AIRWAY PRESSURE MONITOR 04/05/1984
K854934 RESPIRATORY SUPPORT PRODUCTS, INC. VENTILATOR PRESSURE ALARM MODEL VPA-100 12/24/1985
K902276 RESPIRONICS, INC. RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.) 08/17/1990
K904935 RESPIRONICS, INC. RESPIRONICS' DIGITAL MANOMETER 04/03/1991
K820720 RV SYSTEMS RESPIRATOR MONITOR 04/26/1982
K943146 S & M INSTRUMENT CO. PORTA-RESP MONITOR 11/28/1994
K810648 SECHRIST INDUSTRIES, INC. SECHRIST AIRWAY PRESSURE MONITOR #400 03/20/1981
K861330 SECHRIST INDUSTRIES, INC. SECHRIST AIRWAY PRESSURE MONITOR MODEL 600 04/11/1986
K973347 SPIRACLE TECHNOLOGY TSX PRM PULMONARY RESUSCITATION MONITOR 07/23/1998
K790370 THE JOHN BUNN CO. BUNN MODEL #40 LOW PRESSURE ALARM 03/28/1979
K780863 THE JOHN BUNN CO. MODEL 65 HIGH & LOW PRESSURE ALARM 08/21/1978
K782174 THOMPSON RESPIRATION PRODUCTS, INC. PRESSURE ALARM 01/22/1979
K781697 TIMETER INSTRUMENT CORP. PRESSURE, LOW/HIGH MODEL C1070 10/27/1978
K802054 TRAVENOL LABORATORIES, S.A. TRAVENOL ULTRASONIC NEBULIZER CUPS 12/01/1980
K890010 TRUDELL MEDICAL CM 7000MR 06/12/1989
K120118 VENTLAB CORP. VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER 05/24/2012
K050309 VIASYS MEDSYSTEMS PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 03/25/2005
K022402 VITAL SIGNS, INC. DISPOSABLE PRESSURE MANOMETER 08/22/2002
K821667 VITAL SIGNS, INC. SINGLE USE NON-CONDUCTIVE CIRC. DISCON 06/24/1982
K103639 VORTRAN MEDICAL TECHNOLOGY 1, INC. VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC 09/15/2011
K143148 Westmed, Inc. Disposable Pressure Manometer (DPM) 8/11/2015


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