Product code BZM— Anesthesiology

FDA has cleared 26 devices under product code BZM between 1977 and 2011, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20111 clearance
• 20091 clearance
• 20071 clearance
• 20021 clearance
• 19982 clearances
• 19961 clearance
• 19931 clearance
• 19911 clearance
• 19901 clearance
• 19882 clearances
• 19874 clearances
• 19861 clearance
• 19852 clearances
• 19842 clearances
• 19821 clearance

• Medical Graphics Corp.7 clearances
• Karmelsonix3 clearances
• Cybermedic, Inc.2 clearances
• Cdx Corp.2 clearances
• Vacumetrics, Inc.1 clearance
• Stethographics, Inc.1 clearance
• Spirometrics, Inc.1 clearance
• Puritan Bennett Corp.1 clearance
• Orca Diagnostics Corp.1 clearance
• Medimicro Systems, Inc.1 clearance

• K102229 — PULMOTRACK 2020 SYSTEMKarmelsonix·2011-03-04
• K090863 — PERSONAL WHEEZOMETERKarmelsonix·2009-09-21
• K071955 — WIM-PC, MODEL 1010Karmelsonix·2007-11-01
• K012387 — STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMStethographics, Inc.·2002-04-23
• K980878 — PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.·1998-12-28
• K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.·1998-07-21
• K955432 — CPX, CCM, CATH WITH 15% CO2Medical Graphics Corp.·1996-07-01
• K923209 — MEDGRAPHICS EXERCISE CONSULTMedical Graphics Corp.·1993-03-11
• K911143 — PB100 DIAGNOSTIC SPIROMETERPuritan Bennett Corp.·1991-11-29
• K896345 — EXERCISE EVALUATION SYSTEM 2010Medical Graphics Corp.·1990-01-20
• K880550 — BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYSMedimicro Systems, Inc.·1988-07-25
• K874902 — SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERYGomi Medical Instruments·1988-06-07
• K871711 — MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEMMedical Graphics Corp.·1987-09-25
• K864911 — EXERSYSTEM(TM) MMC 5000Med Science·1987-08-21
• K863953 — SPIROMETRICS MODEL 2500 FLOWMATE(TM)Spirometrics, Inc.·1987-01-15
• K864885 — SPIROVISIONFuturemed Div. of Future Impex Corp.·1987-01-15
• K861929 — PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070Medical Graphics Corp.·1986-09-26
• K853190 — SUPERSPIROCdx Corp.·1985-09-26
• K851706 — UNIVERSAL COMPUTER INTERFACE SYSTEMVacumetrics, Inc.·1985-05-03
• K842782 — PHYSIOLOGICAL ANALYZER CM-710Cybermedic, Inc.·1984-08-17
• K831586 — CM-VII PHYSIOLOGIC ANALYZERCybermedic, Inc.·1984-03-19
• K820035 — CDX 200Cdx Corp.·1982-03-10
• K801495 — CARDIO-PULMONARY EXERCISE STRESS SYSTEMMedical Graphics Corp.·1980-07-21
• K801496 — PULMONARY LAB AUTOMATION SYSTEMMedical Graphics Corp.·1980-07-21
• K791229 — CYBER DX 100Cyber Diagnostics·1979-07-30
• K771371 — SCREENING COMPUTEO SC-20Cavitron Corp.·1977-08-04