CCL · Class II · 21 CFR 868.1720

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

Leading manufacturers include Salter Labs, Hewlett-Packard Co. and Maxtec, LLC.

122
Total
122
Cleared
118d
Avg days
1976
Since
122 devices
25–48 of 122
Cleared Nov 13, 1997
TED 191
K963177
Teledyne Brown Engineering
Anesthesiology · 456d
Cleared Nov 25, 1996
VENTREX OXYGEN SENSOR
K963415
Ventrex, LLC
Anesthesiology · 87d
Cleared Nov 01, 1996
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
K943824
Ametek, Inc.
Anesthesiology · 914d
Cleared Jul 25, 1996
MINIOX 3000 OXYGEN MONITOR
K961644
Minesafety Appliances Co.
Anesthesiology · 87d
Cleared Jan 11, 1996
OXYCHECK OXYGEN MONITOR
K951038
Oxycheck, Inc.
Anesthesiology · 310d
Cleared Jun 21, 1995
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
K941793
Mountain Medical Equipment, Inc.
Anesthesiology · 436d
Cleared Nov 08, 1994
OXYGEN CONCENTRATION INDICATOR
K944654
Aequitron Medical, Inc.
Anesthesiology · 48d
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 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 Oct 31, 1989
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
K894918
Mennen Medical, Inc.
Anesthesiology · 90d
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 Jun 15, 1987
MODEL TPC-1A OXYGEN ANALYZER
K872001
Medical, Inc.
Anesthesiology · 20d
Cleared Oct 15, 1986
MODEL A-1 OXYGEN ANALYZER
K863806
Medical, Inc.
Anesthesiology · 15d
Cleared May 02, 1986
SERVO GAS MONITOR 120
K861625
Siemens Elema AB
Anesthesiology · 3d
Cleared Dec 11, 1985
EMERSON MODEL 3MV-OAA ALARM MODULE
K854799
J. H. Emerson Co.
Anesthesiology · 9d
Cleared Oct 29, 1985
DMA OXYGEN MONITOR
K852823
Ferguson Medical
Anesthesiology · 120d