FDA 510(k) Applications for Medical Device Product Code "BZC"
(Calculator, Pulmonary Function Data)

FDA 510(k) Number Applicant Device Name Decision Date
K935309 ACETYLENE GAS CO. LUNG DIFFUSION 09/27/1994
K952542 ACKRAD LABORATORIES ACKRAD ESOPHAGEAL BALLOON CATHETER SET 04/23/1996
K883732 ADVANCED SIGNAL PROCESSING, INC. ARGIS PULMONARY FUNCTION TESTING SYSTEM 03/09/1989
K945213 AEROSPORT, INC. TEEN 100 05/25/1995
K900696 BICORE MONITORING SYSTEMS BIORE CP-100 CARDIOPULMONARY MONITOR 11/29/1990
K892121 BIOCOM INTL., INC. SPIRO-LINK REAL TIME SPIROMETRY SYSTEM 06/16/1989
K830954 BRADLEY, CAMPBELL & CARNEY ACOH WELLNESS TESTER 06/10/1983
K802920 C.R. BARD, INC. INSPIRON PULMONARY FUNCTION ANALYZER 02/23/1981
K803255 CARDIO PULMONARY INSTRUMENTS AUTOMATED PULMONARY FUNCTION LABORATORY 01/28/1981
K810196 CARDIO PULMONARY INSTRUMENTS SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM 02/05/1981
K810243 CARDIO PULMONARY INSTRUMENTS SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME 02/12/1981
K982487 CARDIOPULMONARY TECHNOLOGIES, INC. CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO 10/14/1998
K150810 CareFusion Germany 234 GmbH Vyntus / SentrySuite Product Line 8/14/2015
K133925 CAREFUSION GERMANY 234 GMBH VYNTUS/ SENTRYSUITE PRODUCT LINE 8/22/2014
K770532 CAVITRON CORP. PC-30 PULMONARY COMPUTER 04/05/1977
K802928 CAVITRON CORP. SPIROMETRIC COMPUTER #SC-10 12/17/1980
K011344 COLLINS MEDICAL, INC. INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 05/17/2002
K854626 COMPUMED, INC. COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B 02/28/1986
K001631 CORTEX BIOPHYSIK GMBH CORTEX METAMAX 02/22/2001
K963373 COSMED S.R.L. COSMED K4 09/10/1997
K001174 COSMED S.R.L. COSMED QUARK 01/11/2001
K951157 CREATIVE BIOMEDICS, INC. DX1-PORTABLE 08/11/1995
K964939 CREATIVE BIOMEDICS, INC. THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS 03/06/1997
K861418 CYBERMEDIC, INC. "SPINNAKER" 05/09/1986
K842760 CYBERMEDIC, INC. LUNG ANALYZER CM-310 07/26/1984
K800547 CYBERMEDIC, INC. MEDISTOR III LUNG ANALYZER 03/25/1980
K790185 ELECTRONICS FOR MEDICINE, INC. MODEL V 4207 INTEGRATING PLUG-IN 02/16/1979
K992214 ERICH JAEGER B.V. OXYCON PRO 02/22/2000
K001502 ERICH JAEGER GMBH AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO 07/12/2000
K023120 ERICH JAEGER GMBH OXYCON MOBILE 11/12/2003
K853443 ERICH JAEGER, INC. ALVEO-DIFFUSION TEST 02/21/1986
K843852 ERICH JAEGER, INC. APTA-BRONCHOSCREEN 11/01/1984
K843848 ERICH JAEGER, INC. AW TEST 11/01/1984
K843860 ERICH JAEGER, INC. OXYSCREEN 12/27/1984
K843849 ERICH JAEGER, INC. PNEUMOSCREEN 10/16/1984
K810751 GENERAL ELECTRIC CO. PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF 04/10/1981
K905480 GRANDCOR MEDICAL SYSTEMS SPIROSCOPE 05/06/1991
K946077 HANS RUDOLPH, INC. DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS 09/15/1995
K801088 HOGAN/COLOGNE ENT. F.R.C. APPARATUS 06/17/1980
K780322 HOSPAL MEDICAL CORP. ANALYZER, PULMONARY FUNCTION 03/14/1978
K895963 INFRASONICS CORP. MODIFIED "STAR CALC" 03/16/1990
K875027 INFRASONICS CORP. STAR CALC 08/16/1988
K102047 INNOVISION A/S LCI OPTION FOR INNOCOR 11/01/2011
K812001 JONES MEDICAL INSTRUMENT CO. OSCILLAIRE 08/20/1981
K851805 LIFE PRODUCTS, INC. LPA-3 PRINTER 07/08/1985
K921306 MED SCIENCE ARGIS PULMONARY FUNCTION TESTING SYSTEM 06/25/1993
K840711 MED-SCIENCE ELECTRONICS, INC. PULMONARY FUNCTION SYS-3000 04/02/1984
K893845 MEDICAL ASSOCIATED SERVICES, INC. "PEDS" WATER FILLED CATHETER/TRANSDUCER SYSTEM 10/27/1989
K801497 MEDICAL GRAPHICS CORP. INFANT VENTILATORY MEASUREMENT SYSTEM 10/03/1980
K822986 MEDICAL GRAPHICS CORP. PULMONARY FUNCTION LAB SYSTEM 1070 11/16/1982
K894839 MEDICAL, INC. OS-1 OCCLUSION SYSTEM - 1 10/24/1989
K913681 MULTISPIRO, INC. MULTISPIRO-BREEZE 07/02/1992
K942864 NORDAN SMITH WELDING SUPPLIES LUNG DIFFUSION 03/03/1995
K963380 NOVAMETRIX MEDICAL SYSTEMS, INC. CO 2 SMO PLUS 01/22/1997
K982499 NOVAMETRIX MEDICAL SYSTEMS, INC. COSMO PLUS WITH NICO, MODEL 8200 10/16/1998
K964360 NOVAMETRIX MEDICAL SYSTEMS, INC. VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 04/04/1997
K960831 NOVAMETRIX MEDICAL SYSTEMS, INC. VENTRAK RMMS 1550 05/29/1996
K960121 P.K. MORGAN LTD. AUTOLINK BODY PLETHYSMOGRAPH 01/09/1997
K954730 P.K. MORGAN LTD. BENCHMARK TRANSFER TEST 04/01/1997
K953990 P.K. MORGAN LTD. TRANSFLOW TEST 12/09/1996
K941843 PARVO MEDICS, INC. MMS-2400 06/16/1995
K892670 PHYSIO-DYNE INSTRUMENT CORP. PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE) 09/22/1989
K801920 PULMONARY TESTING SYSTEMS SYSTEM 80 COMPUTERIZED SPIROMETER 10/03/1980
K801918 PULMONARY TESTING SYSTEMS SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO 10/03/1980
K801919 PULMONARY TESTING SYSTEMS SYSTEM 88 COMPUTERIZED DIFFUSION ANALY 10/03/1980
K133051 PULMONE ADVANCED MEDICAL DEVICES, LTD PULMONE MINIBOX PFT TM 05/02/2014
K802116 PURITAN BENNETT CORP. ANESTHESIA GAS MACHINE 10/03/1980
K881235 QUINTON, INC. Q-PLEX 1 03/31/1989
K915686 SENSORMEDICS CORP. MODEL 2900 METABOLIC MEASUREMENT CART 12/01/1992
K915833 SENSORMEDICS CORP. SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART 12/02/1992
K970840 SIMTEC, INC. INTELLIFLOW RESPIRATORY ANALYZER 11/26/1997
K801597 SPITAL MEDICAL, INC. PFT CALIBRATOR 08/04/1980
K855070 TELEDYNE AVIONICS DIV. OF TELEDYNE SPIROMETER MODEL TS-200 SLZ 7541 01/30/1986
K801526 THE DEVILBISS CO. SURVEYOR I, RESPIRATORY COMPUTER SYSTEM 07/21/1980
K860844 VACUMETRICS, INC. VISTA INTERFACE SYSSTEM 04/02/1986
K072323 VIASYS HEALTHCARE GMBH MASTERSCREEN & OXYCON CPX 10/10/2007
K040698 VIASYS HEALTHCARE GMBH MASTERSCREEN CPX AND OXYCON CPX 04/07/2004
K791503 VITALOGRAPH LTD. VITALOGRAPH FUNCTION ANALYZER 08/16/1979
K831777 WARREN E. COLLINS, INC. COLLINS DS 08/31/1983
K831779 WARREN E. COLLINS, INC. COLLINS EAGLE II 08/26/1983
K780328 WARREN E. COLLINS, INC. PULMONARY FUNCTION TESTER, COMPUTERIZED 03/14/1978
K831778 WARREN E. COLLINS, INC. RS-RESIDUAL VOLUME SYSTEM 08/31/1983
K852909 WATERS INSTRUMENTS, INC. MVP - 6000 11/14/1985
K052328 ZAN MESSGERATE GMBH ZAN LUNG-FUNCTION LAB 12/22/2005


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