BZK · Class II · 21 CFR 868.1850

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

Leading manufacturers include Ohmeda Medical, Boehringer Laboratories and Ohio Medical Products.

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 Nov 02, 2006
GAS MODULE SE, MODEL 0998-00-0481-02
K062754
Datascope Corp.
Anesthesiology · 49d
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 Sep 27, 1990
PARTNER VOLUME MONITOR
K901885
Bird Products Corp.
Anesthesiology · 154d
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 Oct 04, 1984
OHMEDA RM311 RESPIROMETER
K843799
Ohmeda Medical
Anesthesiology · 7d
Cleared Oct 04, 1984
OHMEDA RM121 RESPIROMETER
K843800
Ohmeda Medical
Anesthesiology · 7d
Cleared Mar 02, 1984
MEDISHIELD PVM RESPIROMETER
K840453
Ohio Medical Products
Anesthesiology · 30d
Cleared Jul 12, 1983
PORTABLE MONITORING & SCREENING SPIROM.
K822689
Boehringer Laboratories
Anesthesiology · 312d
Cleared May 09, 1983
SPIROMED RESPIROMETER
K831237
Draeger Medical, Inc.
Anesthesiology · 24d
Cleared Feb 24, 1983
COMPUTERIZED SPIROMETRY SYSTEM
K823922
Ohio Medical Products
Anesthesiology · 58d
Cleared May 08, 1980
RMS 111F RESPIRATORY MONITORING SYSTEM
K800086
The Perkin-Elmer Corp.
Anesthesiology · 115d
Cleared Jan 31, 1979
SPIROMETER, MINI POSITIVE
K782145
Boehringer Laboratories
Anesthesiology · 35d
Cleared Jan 31, 1978
SPIROMETER, MONITORING W/ALARM
K780064
Ohio Medical Products
Anesthesiology · 19d
Cleared Dec 09, 1976
POSITIVE DISPLACEMENT SPIROMETER
K760971
Boehringer Laboratories
Anesthesiology · 35d

About Product Code BZK - Regulatory Context