FDA 510(k) Applications for Medical Device Product Code "BZM"
(Calculator, Pulmonary Function Interpretator (Diagnostic))

FDA 510(k) Number Applicant Device Name Decision Date
K771371 CAVITRON CORP. SCREENING COMPUTEO SC-20 08/04/1977
K820035 CDX CORP. CDX 200 03/10/1982
K853190 CDX CORP. SUPERSPIRO 09/26/1985
K791229 CYBER DIAGNOSTICS CYBER DX 100 07/30/1979
K831586 CYBERMEDIC, INC. CM-VII PHYSIOLOGIC ANALYZER 03/19/1984
K842782 CYBERMEDIC, INC. PHYSIOLOGICAL ANALYZER CM-710 08/17/1984
K864885 FUTUREMED DIV. OF FUTURE IMPEX CORP. "SPIROVISION" 01/15/1987
K874902 GOMI MEDICAL INSTRUMENTS SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY 06/07/1988
K980878 KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. PULMOTRACK,MODEL 1010 12/28/1998
K071955 KARMEL SONIX WIM-PC, MODEL 1010 11/01/2007
K090863 KARMELSONIX PERSONAL WHEEZOMETER 09/21/2009
K102229 KARMELSONIX PULMOTRACK 2020 SYSTEM 03/04/2011
K864911 MED SCIENCE EXERSYSTEM(TM) MMC 5000 08/21/1987
K801495 MEDICAL GRAPHICS CORP. CARDIO-PULMONARY EXERCISE STRESS SYSTEM 07/21/1980
K955432 MEDICAL GRAPHICS CORP. CPX, CCM, CATH WITH 15% CO2 07/01/1996
K896345 MEDICAL GRAPHICS CORP. EXERCISE EVALUATION SYSTEM 2010 01/20/1990
K923209 MEDICAL GRAPHICS CORP. MEDGRAPHICS EXERCISE CONSULT 03/11/1993
K871711 MEDICAL GRAPHICS CORP. MEDICAL GRAPHICS "DESKTOP DIAGNOSTIC" SYSTEM 09/25/1987
K861929 MEDICAL GRAPHICS CORP. PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 09/26/1986
K801496 MEDICAL GRAPHICS CORP. PULMONARY LAB AUTOMATION SYSTEM 07/21/1980
K880550 MEDIMICRO SYSTEMS, INC. BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS 07/25/1988
K974200 ORCA DIAGNOSTICS CORP. ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM 07/21/1998
K911143 PURITAN BENNETT CORP. PB100 DIAGNOSTIC SPIROMETER 11/29/1991
K863953 SPIROMETRICS, INC. SPIROMETRICS MODEL 2500 FLOWMATE(TM) 01/15/1987
K012387 STETHOGRAPHICS, INC. STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM 04/23/2002
K851706 VACUMETRICS, INC. UNIVERSAL COMPUTER INTERFACE SYSTEM 05/03/1985


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