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
49–72 of 288
Cleared Jun 20, 2014
INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
K132489
Inogen, Inc.
Anesthesiology · 316d
Cleared Jun 06, 2014
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
K132205
Inova Labs, Inc.
Anesthesiology · 325d
Cleared Apr 25, 2014
2300 SERIES MGO PORTABLE OXYGEN
K134023
Ultra Electronics Limited Precision Air & Land SY
Anesthesiology · 116d
Cleared Feb 21, 2014
OXYGEN GENERATOR LIQUEFIER - (OGL)
K131990
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 238d
Cleared Nov 27, 2013
ROGS
K131016
Molecular Products , Ltd.
Anesthesiology · 230d
Cleared Feb 28, 2013
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
K123738
Nidek Medical Products, Inc.
Anesthesiology · 85d
Cleared Oct 25, 2012
OMNI 3 OXYGEN SYSTEM
K120785
Caire, Inc.
Anesthesiology · 224d
Cleared Sep 21, 2012
TROOPER OXYGEN CONCENTRATOR
K121260
Vbox, Inc.
Anesthesiology · 148d
Cleared Jul 24, 2012
O2PAK OXYGEN GENERATOR
K120566
Pacific Precision Products
Anesthesiology · 148d
Cleared Jul 17, 2012
A&J 5L POCA SERIES OXYGEN CONCENTRATOR
K121531
Zhongshan A&J Medical Equipment Co., Ltd.
Anesthesiology · 54d
Cleared May 02, 2012
CAIRE COMPANION 5 OXYGEN CONCENTRATOR
K121167
Caire, Inc.
Anesthesiology · 15d
Cleared Dec 28, 2011
LIFECHOICE OXYGEN CONCENTRATOR
K113317
Inova Labs, Inc.
Anesthesiology · 48d
Cleared Nov 04, 2011
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885
Respironics, Inc.
Anesthesiology · 126d
Cleared Jul 01, 2011
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
K103563
Precision Medical, Inc.
Anesthesiology · 207d
Cleared Mar 28, 2011
CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L
K101154
Airsep Corp.
Anesthesiology · 339d
Cleared Apr 02, 2010
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
K091716
Merits Health Products Co., Ltd.
Anesthesiology · 296d
Cleared Oct 23, 2009
GAS TRANSFILL
K091191
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 183d
Cleared Jul 23, 2009
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028
Respironics, Inc.
Anesthesiology · 104d
Cleared May 21, 2009
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751
Invacare Corporation
Anesthesiology · 155d
Cleared Oct 27, 2008
PRECISION OXYGEN CONCENTRATOR
K072348
Precision Medical, Inc.
Anesthesiology · 433d
Cleared Jul 28, 2008
HOMELOX
K081206
Respironics, Inc.
Anesthesiology · 90d
Cleared Dec 12, 2007
THE INVACARE FLYER, MODEL IPC 100
K071928
Invacare Corp.
Anesthesiology · 153d
Cleared Jun 28, 2006
L4 OXYGEN CONCENTRATOR
K061261
Respironics, Inc.
Anesthesiology · 54d
Cleared May 16, 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053230
Merits Health Products Co., Ltd.
Anesthesiology · 179d