CAW · Class II · 21 CFR 868.5440

FDA Product Code CAW: Generator, Oxygen, Portable

Leading manufacturers include Invacare Corp., Mountain Medical Equipment, Inc. and The John Bunn Co..

288
Total
288
Cleared
144d
Avg days
1976
Since
288 devices
97–120 of 288
Cleared Jul 23, 1998
TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
K981078
Transtracheal Systems
Anesthesiology · 121d
Cleared Jan 20, 1998
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605
K972614
Healthdyne Technologies, Inc.
Anesthesiology · 190d
Cleared Nov 17, 1997
CHAD TOTAL O2 DELIVERY SYSTEM
K971889
Chad Therapeutics, Inc.
Anesthesiology · 180d
Cleared Oct 03, 1997
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)
K971947
Sim Italia S.R.L.
Anesthesiology · 128d
Cleared Aug 15, 1997
OXLIFE EXCELL OXYGEN CONCENTRATORS
K971964
Oxlife, Inc.
Anesthesiology · 79d
Cleared Jun 24, 1997
OXYPURE PORTABLE OXYGEN GENERATOR
K971129
Arbor Research Corp.
Anesthesiology · 89d
Cleared Feb 28, 1997
AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
K960309
Airsep Corp.
Anesthesiology · 420d
Cleared Nov 01, 1996
INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
K963042
Sim Italia S.R.L.
Anesthesiology · 88d
Cleared Apr 30, 1996
EMOX
K954506
Medtrak Intl., Inc.
Anesthesiology · 215d
Cleared Mar 15, 1996
OXLIFE OXYGEN CONCENTRATORS
K955549
Oxlife, Inc.
Anesthesiology · 101d
Cleared Jan 29, 1996
SUN MODEL OA 3000 OXYGEN ANALYZER
K952941
Sun Medical Equipment, Inc.
Anesthesiology · 217d
Cleared Nov 09, 1995
5 LPM OXYGEN CONCENTRATOR
K953815
Devilbiss Health Care, Inc.
Anesthesiology · 87d
Cleared Oct 16, 1995
ECO CHECK (ECOVALVE AND OXYGEN MONITOR)
K951882
Airsep Corp.
Anesthesiology · 196d
Cleared Oct 16, 1995
HUMIDIFIER & ACCESSORIES
K953949
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 55d
Cleared Sep 06, 1995
3 LPM OXYGEN CONCENTRATOR
K952037
Devilbiss Health Care, Inc.
Anesthesiology · 128d
Cleared May 27, 1994
H-500 ALLIANCE OXYGEN CONCENTRATOR
K942357
Healthdyne, Inc.
Anesthesiology · 10d
Cleared Aug 06, 1993
MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES
K924818
Invacare Corp.
Anesthesiology · 312d
Cleared Jun 07, 1993
KEYSTONE CONCENTRATOR, MODEL PV5L
K924152
Devilbiss Health Care, Inc.
Anesthesiology · 293d
Cleared Mar 19, 1993
OXYGEN CONCENTRATOR
K924100
Allied Healthcare Products, Inc.
Anesthesiology · 218d
Cleared Jan 15, 1993
SCOTTY
K923650
Mountain Medical Equipment, Inc.
Anesthesiology · 178d
Cleared Jan 07, 1993
OH-500 OXYGEN CONCENTRATOR
K924146
Healthdyne, Inc.
Anesthesiology · 142d
Cleared Sep 23, 1992
ALPINE V
K914916
Mountain Medical Equipment, Inc.
Anesthesiology · 324d
Cleared Sep 15, 1992
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488
Invacare Corp.
Anesthesiology · 343d
Cleared Mar 11, 1992
PORTABLE OXYGEN GENERATOR
K915381
Aequitron Medical, Inc.
Anesthesiology · 103d