BZM — Calculator, Pulmonary Function Interpretor (Diagnostic) Class II

FDA Device Classification

Classification Details

Product Code
BZM
Device Class
Class II
Regulation Number
868.1900
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K102229karmelsonixPULMOTRACK 2020 SYSTEMMarch 4, 2011
K090863karmelsonixPERSONAL WHEEZOMETERSeptember 21, 2009
K071955karmelsonixWIM-PC, MODEL 1010November 1, 2007
K012387stethographicsSTG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMApril 23, 2002
K980878karmel medical acoustic technologiesPULMOTRACK,MODEL 1010December 28, 1998
K974200orca diagnosticsORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMJuly 21, 1998
K955432medical graphicsCPX, CCM, CATH WITH 15% CO2July 1, 1996
K923209medical graphicsMEDGRAPHICS EXERCISE CONSULTMarch 11, 1993
K911143puritan bennettPB100 DIAGNOSTIC SPIROMETERNovember 29, 1991
K896345medical graphicsEXERCISE EVALUATION SYSTEM 2010January 20, 1990
K880550medimicro systemsBURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYSJuly 25, 1988
K874902gomi medical instrumentsSINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERYJune 7, 1988
K871711medical graphicsMEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEMSeptember 25, 1987
K864911med scienceEXERSYSTEM(TM) MMC 5000August 21, 1987
K863953spirometricsSPIROMETRICS MODEL 2500 FLOWMATE(TM)January 15, 1987
K864885futuremed div. of future impexSPIROVISIONJanuary 15, 1987
K861929medical graphicsPULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070September 26, 1986
K853190cdxSUPERSPIROSeptember 26, 1985
K851706vacumetricsUNIVERSAL COMPUTER INTERFACE SYSTEMMay 3, 1985
K842782cybermedicPHYSIOLOGICAL ANALYZER CM-710August 17, 1984