BZK · Class II · 21 CFR 868.1850

FDA Product Code BZK: Spirometer, Monitoring (w/wo Alarm)

Leading manufacturers include Respiratory Motion, Inc., Bear Medical Systems, Inc. and Ohmeda Medical.

61
Total
61
Cleared
107d
Avg days
1976
Since

FDA 510(k) Cleared Spirometer, Monitoring (w/wo Alarm) Devices (Product Code BZK)

61 devices
1–24 of 61
Cleared Dec 18, 2019
BEACON Caresystem Model 00002144
K192584
Mermaid Care A/S
Anesthesiology · 90d
Cleared Dec 17, 2019
ExSpiron 2Xi
K192595
Respiratory Motion
Anesthesiology · 88d
Cleared Oct 24, 2018
Gas Module 3
K180788
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 212d
Cleared Mar 16, 2018
ExSpiron 1Xi
K173181
Respiratory Motion, Inc.
Anesthesiology · 168d
Cleared May 09, 2017
ExSpiron 1Xi
K162131
Respiratory Motion, Inc.
Anesthesiology · 281d
Cleared May 29, 2013
EXSPIRON 1XI
K130170
Respiratory Motion, Inc.
Anesthesiology · 125d
Cleared Sep 26, 2012
EXSPIRON
K120087
Respiratory Motion, Inc.
Anesthesiology · 259d
Cleared Jun 02, 2011
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
K103578
Respironics Novametrix, LLC
Anesthesiology · 178d
Cleared Nov 02, 2006
GAS MODULE SE, MODEL 0998-00-0481-02
K062754
Datascope Corp.
Anesthesiology · 49d
Cleared Sep 07, 2005
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
K051279
Caldyne, Inc.
General Hospital · 113d
Cleared Dec 09, 1998
STARTRACK INFANT GRAPHICS MONITOR
K983274
Nellcor Puritan Bennett, Inc.
Anesthesiology · 83d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K972086
Alexander Mfg. Co.
Anesthesiology · 69d
Cleared Nov 29, 1993
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K932098
Datex Division Instrumentarium Corp.
Anesthesiology · 210d
Cleared Oct 25, 1993
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
K931542
Newport Medical Instruments, Inc.
Anesthesiology · 210d
Cleared Sep 27, 1990
PARTNER VOLUME MONITOR
K901885
Bird Products Corp.
Anesthesiology · 154d
Cleared Jun 07, 1989
MONAGHAN RVM, MODEL 761
K884942
Monaghan Medical Corp.
Anesthesiology · 194d
Cleared Mar 30, 1989
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K890724
Bear Medical Systems, Inc.
Anesthesiology · 45d
Cleared Feb 12, 1988
BEAR NVM-1
K872660
Bear Medical Systems, Inc.
Anesthesiology · 220d
Cleared Jan 28, 1987
RESPIRADYNE II(TM)
K863866
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 117d
Cleared Sep 12, 1986
OHMEDA 5410 VOLUME MONITOR
K862687
Ohmeda Medical
Anesthesiology · 59d
Cleared Sep 12, 1986
OHMEDA 5420 VOLUME MONITOR
K862688
Ohmeda Medical
Anesthesiology · 59d
Cleared Sep 11, 1985
BEAR NICU-1
K853346
Bear Medical Systems, Inc.
Anesthesiology · 30d
Cleared Oct 04, 1984
OHMEDA RM311 RESPIROMETER
K843799
Ohmeda Medical
Anesthesiology · 7d
Cleared Oct 04, 1984
OHMEDA RM121 RESPIROMETER
K843800
Ohmeda Medical
Anesthesiology · 7d

About Product Code BZK - Regulatory Context