BZMClass II
Calculator, Pulmonary Function Interpretor (diagnostic)
Anesthesiology · 21 CFR 868.1900
MDR events4All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances26All time
Recent MDR events
4 adverse event reports on file
Event type breakdown
Malfunction4
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
26 clearances for this product code
- KarmelsonixMar 4, 2011
K102229 · PULMOTRACK 2020 SYSTEM
- KarmelsonixSep 21, 2009
K090863 · PERSONAL WHEEZOMETER
- KarmelsonixNov 1, 2007
K071955 · WIM-PC, MODEL 1010
- Stethographics, Inc.Apr 23, 2002
K012387 · STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
- Karmel Medical Acoustic Technologies , Ltd.Dec 28, 1998
K980878 · PULMOTRACK,MODEL 1010
- Orca Diagnostics Corp.Jul 21, 1998
K974200 · ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
- Medical Graphics Corp.Jul 1, 1996
K955432 · CPX, CCM, CATH WITH 15% CO2
- Medical Graphics Corp.Mar 11, 1993
K923209 · MEDGRAPHICS EXERCISE CONSULT