FDA 510(k) Applications for Medical Device Product Code "BZK"
(Spirometer, Monitoring (W/Wo Alarm))

FDA 510(k) Number Applicant Device Name Decision Date
K832565 AIRCO/OHIO MEDICAL PRODUCTS OHIO 5400 VOLUME MONITOR 09/01/1983
K972086 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 08/12/1997
K853346 BEAR MEDICAL SYSTEMS, INC. BEAR NICU-1 09/11/1985
K872660 BEAR MEDICAL SYSTEMS, INC. BEAR NVM-1 02/12/1988
K822912 BEAR MEDICAL SYSTEMS, INC. BEAR VM-90 VENTILATION MONITOR 11/16/1982
K890724 BEAR MEDICAL SYSTEMS, INC. MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR 03/30/1989
K921717 BICORE MONITORING SYSTEMS BICORE SMARTVALVE OCCLUSION VALVE 11/06/1992
K901885 BIRD PRODUCTS CORP. PARTNER VOLUME MONITOR 09/27/1990
K822689 BOEHRINGER LABORATORIES PORTABLE MONITORING & SCREENING SPIROM. 07/12/1983
K760971 BOEHRINGER LABORATORIES POSITIVE DISPLACEMENT SPIROMETER 12/09/1976
K782145 BOEHRINGER LABORATORIES SPIROMETER, MINI POSITIVE 01/31/1979
K812959 CAIRCO LTD. SPIROX "A" 01/22/1982
K812956 CAIRCO LTD. SPIROX "H" 01/22/1982
K051279 CALDYNE, INC. CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 09/07/2005
K863866 CHESEBROUGH-POND'S U.S.A. CO. RESPIRADYNE II(TM) 01/28/1987
K884910 CYBERMEDIC, INC. MODEL 1010, CY-MET 06/12/1989
K903959 CYBERMEDIC, INC. NEONATAL METASCOPE 11/23/1990
K062754 DATASCOPE CORP. GAS MODULE SE, MODEL 0998-00-0481-02 11/02/2006
K932098 DATEX DIVISION INSTRUMENTARIUM CORP. CAPNOMAC ULTIMA ANESTHESIA MONITOR 11/29/1993
K863538 DICKSTEIN, SHAPIRO & MORIN RESPICENTRAL(TM) 09/24/1986
K831237 DRAEGER MEDICAL, INC. SPIROMED RESPIROMETER 05/09/1983
K792573 EMPIRE PLASTICS MANUFACTURER ALARM USED W/MONITORING SPIROMETER 12/31/1979
K792572 EMPIRE PLASTICS MANUFACTURER EMPIRE SPIROMETER 12/19/1979
K840975 J.M. LABORATORIES, INC. RICO RESPIRATION MONITOR 03/30/1984
K812046 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. TIDAL VOLUME MONITOR 150 08/07/1981
K884942 MONAGHAN MEDICAL CORP. MONAGHAN RVM, MODEL 761 06/07/1989
K903674 NATIONAL MEDICAL SALES, INC. MODEL 295 ELECTRONIC RESPIROMETER 01/04/1991
K983274 NELLCOR PURITAN BENNETT, INC. STARTRACK INFANT GRAPHICS MONITOR 12/09/1998
K931542 NEWPORT MEDICAL INSTRUMENTS, INC. NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR 10/25/1993
K864886 NIMS/RESPITRACE CORP. RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL 03/06/1987
K884959 NON-INVASIVE MONITORING SYSTEMS, INC. RESPITRAK 06/08/1989
K091853 NSPIRE HEALTH, INC. WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 09/21/2009
K823922 OHIO MEDICAL PRODUCTS COMPUTERIZED SPIROMETRY SYSTEM 02/24/1983
K840453 OHIO MEDICAL PRODUCTS MEDISHIELD PVM RESPIROMETER 03/02/1984
K780064 OHIO MEDICAL PRODUCTS SPIROMETER, MONITORING W/ALARM 01/31/1978
K862687 OHMEDA MEDICAL OHMEDA 5410 VOLUME MONITOR 09/12/1986
K862688 OHMEDA MEDICAL OHMEDA 5420 VOLUME MONITOR 09/12/1986
K843800 OHMEDA MEDICAL OHMEDA RM121 RESPIROMETER 10/04/1984
K843799 OHMEDA MEDICAL OHMEDA RM311 RESPIROMETER 10/04/1984
K830995 P.K. MORGAN INSTRUMENTS, INC. POCKET SPIROMETER 04/28/1983
K823555 PENLON, INC. MAGTARAK RESPIRATORY MONITOR & FLOW SENS 01/05/1983
K162131 Respiratory Motion Inc. ExSpiron 1Xi 05/09/2017
K173181 Respiratory Motion Inc. ExSpiron 1Xi 03/16/2018
K120087 RESPIRATORY MOTION, INC. EXSPIRON 09/26/2012
K130170 RESPIRATORY MOTION, INC. EXSPIRON 1XI 05/29/2013
K080652 RESPIRONICS NOVAMETRIX LLC MERCURY VCO2 MODULE WITH CAPNOSTAT 5 06/20/2008
K091459 RESPIRONICS NOVAMETRIX LLC PHILIPS NM3 MONITOR, MODEL 7900 07/28/2009
K092217 RESPIRONICS NOVAMETRIX, INC. MERCURY VCO2 08/21/2009
K103578 RESPIRONICS NOVAMETRIX, LLC PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST 06/02/2011
K823783 RESPITRACE CORP. RESPICOMB 01/11/1984
K854956 RESPITRACE CORP. RESPIGRAPH 03/20/1986
K772016 RESPITRACE CORP. RESPITRACE 01/26/1978
K823780 RESPITRACE CORP. RESPITRACE 300SC 01/20/1984
K852692 RESPITRACE CORP. RESPITRACE 300SC 07/15/1985
K823782 RESPITRACE CORP. RESPITRACE SYSTEM 03/07/1983
K890932 SIEMENS LIFE SUPPORT SYSTEMS CAV 3.0C SOFTWARE PROGRAM 06/12/1989
K800086 THE PERKIN-ELMER CORP. RMS 111F RESPIRATORY MONITORING SYSTEM 05/08/1980
K770907 TIMETER INSTRUMENT CORP. SPIROMETEO EXHAUST 07/05/1977


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