CCL · Class II · 21 CFR 868.1720

FDA Product Code CCL: Analyzer, Gas, Oxygen, Gaseous-phase

Leading manufacturers include Salter Labs, Catalyst Research Corp. and Ceramatec, Inc..

122
Total
122
Cleared
118d
Avg days
1976
Since
122 devices
49–72 of 122
Cleared Nov 08, 1994
OXYGEN CONCENTRATION INDICATOR
K944654
Aequitron Medical, Inc.
Anesthesiology · 48d
Cleared Jun 14, 1994
MINIOX 1000 OXYGEN CONCENTRATION INDICATOR
K935364
Minesafety Appliances Co.
Anesthesiology · 222d
Cleared Mar 05, 1993
PRO2 OXYGEN ANALYZER
K922438
Martech Medical Products, Inc.
Anesthesiology · 287d
Cleared Jan 27, 1993
VTI OXYGEN ANALYZER
K922738
Vascular Technology Incorporated
Anesthesiology · 233d
Cleared Aug 27, 1992
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338
Puritan Bennett Corp.
Anesthesiology · 216d
Cleared Jul 17, 1992
OXYGEN SENSING DEVICE, MODIFICATION
K913392
Devilbiss Health Care, Inc.
Anesthesiology · 354d
Cleared Aug 22, 1991
BIOCHEM TEMPERATURE/ FIO2 MODULE
K910381
Biochem International, Inc.
Anesthesiology · 205d
Cleared Jun 18, 1991
CERION HAND HELD OXYGEN ANALYZER
K911344
Ceramatec, Inc.
Anesthesiology · 83d
Cleared Mar 09, 1990
AG-820PA FI02 MODULE
K896359
Nihon Kohden America, Inc.
Anesthesiology · 123d
Cleared Jan 24, 1990
SPACELABS' MODEL 90514, MULTIGAS ANALYZER
K896427
Spacelabs, Inc.
Anesthesiology · 77d
Cleared Nov 21, 1989
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
K890058
Vascular Technology Incorporated
Anesthesiology · 319d
Cleared Oct 31, 1989
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
K894918
Mennen Medical, Inc.
Anesthesiology · 90d
Cleared Aug 31, 1989
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
K891674
Preemicare Corp.
Anesthesiology · 163d
Cleared May 25, 1989
OXITRON OXYGEN SENSOR
K890144
Oxitron Medical Products
Anesthesiology · 132d
Cleared May 22, 1989
OXITRON OXYGEN ANALYZER
K890958
Oxitron Medical Products
Anesthesiology · 84d
Cleared Nov 02, 1988
MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.
K882352
Clinical Information Systems, Inc.
Anesthesiology · 148d
Cleared Sep 30, 1988
LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
K880378
Lifecare Services, Inc.
Anesthesiology · 247d
Cleared Sep 12, 1988
MULTINEX MONITOR (MODIFICATION)
K883254
Datascope Corp.
Anesthesiology · 41d
Cleared Aug 24, 1988
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743
Ohmeda Medical
Anesthesiology · 54d
Cleared Aug 19, 1988
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
K881663
Salter Labs
Anesthesiology · 126d
Cleared Jun 16, 1988
SL02 OXYGEN ANALYZER
K881472
Salter Labs
Anesthesiology · 70d
Cleared Jun 16, 1988
SL01 OXYGEN ANALYZER
K881473
Salter Labs
Anesthesiology · 70d
Cleared Mar 29, 1988
LC OXYGEN ANALYZER
K875183
Ametek/Thermox Instruments Division
Anesthesiology · 98d
Cleared Mar 21, 1988
CERION OXY THRESHOLD ALARM
K880448
Ceramatec, Inc.
Anesthesiology · 48d