BZM · Class II · 21 CFR 868.1900

FDA Product Code BZM: Calculator, Pulmonary Function Interpretor (diagnostic)

Leading manufacturers include Medical Graphics Corp., Karmelsonix and Stethographics, Inc..

26
Total
26
Cleared
141d
Avg days
1977
Since

FDA 510(k) Cleared Calculator, Pulmonary Function Interpretor (diagnostic) Devices (Product Code BZM)

26 devices
1–24 of 26
Cleared Mar 04, 2011
PULMOTRACK 2020 SYSTEM
K102229
Karmelsonix
Anesthesiology · 207d
Cleared Sep 21, 2009
PERSONAL WHEEZOMETER
K090863
Karmelsonix
Anesthesiology · 175d
Cleared Nov 01, 2007
WIM-PC, MODEL 1010
K071955
Karmelsonix
Anesthesiology · 108d
Cleared Apr 23, 2002
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
K012387
Stethographics, Inc.
Anesthesiology · 270d
Cleared Dec 28, 1998
PULMOTRACK,MODEL 1010
K980878
Karmel Medical Acoustic Technologies , Ltd.
Anesthesiology · 294d
Cleared Jul 21, 1998
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
K974200
Orca Diagnostics Corp.
Anesthesiology · 253d
Cleared Jul 01, 1996
CPX, CCM, CATH WITH 15% CO2
K955432
Medical Graphics Corp.
Anesthesiology · 216d
Cleared Mar 11, 1993
MEDGRAPHICS EXERCISE CONSULT
K923209
Medical Graphics Corp.
Anesthesiology · 253d
Cleared Nov 29, 1991
PB100 DIAGNOSTIC SPIROMETER
K911143
Puritan Bennett Corp.
Anesthesiology · 260d
Cleared Jan 20, 1990
EXERCISE EVALUATION SYSTEM 2010
K896345
Medical Graphics Corp.
Anesthesiology · 78d
Cleared Sep 25, 1987
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
K871711
Medical Graphics Corp.
Anesthesiology · 147d
Cleared Jan 15, 1987
SPIROVISION
K864885
Futuremed Div. of Future Impex Corp.
Anesthesiology · 34d
Cleared Sep 26, 1986
PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
K861929
Medical Graphics Corp.
Anesthesiology · 129d
Cleared Jul 21, 1980
CARDIO-PULMONARY EXERCISE STRESS SYSTEM
K801495
Medical Graphics Corp.
Anesthesiology · 25d
Cleared Jul 21, 1980
PULMONARY LAB AUTOMATION SYSTEM
K801496
Medical Graphics Corp.
Anesthesiology · 25d
Cleared Aug 04, 1977
SCREENING COMPUTEO SC-20
K771371
Cavitron Corp.
Anesthesiology · 10d

About Product Code BZM - Regulatory Context