CAW · Class II · 21 CFR 868.5440

FDA Product Code CAW: Generator, Oxygen, Portable

Leading manufacturers include Invacare Corp., Healthdyne, Inc. and Respironics, Inc..

287
Total
287
Cleared
144d
Avg days
1976
Since
287 devices
49–72 of 287
Cleared Jul 02, 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386
Invacare Corp.
Anesthesiology · 146d
Cleared Mar 21, 2001
VENTURE HOME FILL II, MODEL IOH 200
K003939
Invacare Corp.
Anesthesiology · 90d
Cleared Oct 22, 1999
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627
Invacare Corp.
Anesthesiology · 372d
Cleared Oct 08, 1999
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
K993088
Puritan Bennett Corp.
Anesthesiology · 22d
Cleared Dec 18, 1998
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777
Invacare Corp.
Anesthesiology · 53d
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 Jan 07, 1993
OH-500 OXYGEN CONCENTRATOR
K924146
Healthdyne, Inc.
Anesthesiology · 142d
Cleared Sep 15, 1992
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488
Invacare Corp.
Anesthesiology · 343d
Cleared Oct 26, 1990
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087
Invacare Corp.
Anesthesiology · 52d
Cleared Oct 12, 1990
V-LINK
K903608
GE Medical Systems
Radiology · 64d
Cleared Nov 21, 1989
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177
Puritan Bennett Corp.
Anesthesiology · 103d
Cleared Oct 31, 1989
MODEL 590 OXYGEN CONCENTRATOR
K895141
Puritan Bennett Corp.
Anesthesiology · 76d
Cleared May 25, 1989
MOBILAIRE V OXYGEN CONCENTRATOR
K891488
Invacare Corp.
Anesthesiology · 69d
Cleared Jan 31, 1989
H-3000 OXYGEN CONCENTRATOR
K890150
Healthdyne, Inc.
Anesthesiology · 18d
Cleared Apr 04, 1986
SILENT PARTNER MODEL 10-2001
K861011
Medical Devices, Inc.
Anesthesiology · 17d
Cleared Apr 04, 1986
SILENT PARTNER MODEL 10-1001
K861012
Medical Devices, Inc.
Anesthesiology · 17d
Cleared Jan 03, 1986
OXYGEN CONCENTRATOR, MODEL BX-5000
K854374
Healthdyne, Inc.
Anesthesiology · 65d
Cleared Jul 29, 1985
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR
K851435
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
PRIME AIRE O2 PLUS 2
K851437
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439
Invacare Corp.
Anesthesiology · 110d
Cleared Aug 22, 1984
COMPANION 492 OXYGEN CONCENTRATOR
K843243
Puritan Bennett Corp.
Anesthesiology · 368d