BTL · Class II · 21 CFR 868.5925

FDA Product Code BTL: Ventilator, Emergency, Powered (resuscitator)

Leading manufacturers include Allied Healthcare Products, Inc., Pneupac , Ltd. and Life Support Products, Inc..

100
Total
100
Cleared
156d
Avg days
1977
Since
100 devices
25–48 of 100
Cleared May 18, 2009
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
K083507
Allied Healthcare Products, Inc.
Anesthesiology · 173d
Cleared May 14, 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385
Allied Healthcare Products, Inc.
Anesthesiology · 178d
Cleared Mar 06, 2009
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
K081330
O-Two Medical Technologies, Inc.
Anesthesiology · 298d
Cleared Aug 15, 2008
MASS CASUALTY VENTILATOR, MODEL MCV100
K080063
Allied Healthcare Products, Inc.
Anesthesiology · 218d
Cleared Jun 20, 2008
MACS CPAP SYSTEM
K080692
Airon Corporation
Anesthesiology · 101d
Cleared May 23, 2008
VAR MONITOR
K073261
Vortran Medical Technology 1, Inc.
Anesthesiology · 185d
Cleared Mar 06, 2008
PORTABLE VENTILATOR, MODEL EPV-100
K072214
Allied Healthcare Products, Inc.
Anesthesiology · 210d
Cleared Oct 04, 2007
PNEUPAC VR1 AIR MIX
K071527
Smiths Medical International , Ltd.
Anesthesiology · 122d
Cleared Sep 06, 2007
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
K071221
Automedx, Inc.
Anesthesiology · 127d
Cleared Jul 13, 2007
AUTOVENT 4000 WITH CPAP
K070636
Allied Healthcare Products, Inc.
Anesthesiology · 128d
Cleared May 03, 2007
AUTOVENT MODEL 4000
K070120
Allied Healthcare Products, Inc.
Anesthesiology · 111d
Cleared Apr 20, 2007
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K070210
Ohmeda Medical
Anesthesiology · 88d
Cleared Oct 28, 2005
UNI-VENT MODEL 73X
K051476
Impact Instrumentation, Inc.
Anesthesiology · 147d
Cleared Sep 28, 2005
CAREVENT ATV+ AND CAREVENT MRI
K051469
O-Two Medical Technologies, Inc.
Anesthesiology · 117d
Cleared Aug 30, 2005
CAREVENT CA AND DRA
K051889
O-Two Medical Technologies, Inc.
Anesthesiology · 49d
Cleared Aug 05, 2005
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
K051322
Smiths Medical International , Ltd.
Anesthesiology · 77d
Cleared Apr 22, 2005
BABYPAC
K043495
Smiths Medical International Ltd., Luton
Anesthesiology · 126d
Cleared Jul 15, 2004
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
K041473
Vortran Medical Technology 1, Inc.
Anesthesiology · 43d
Cleared May 27, 2004
COMPPAC 200HD
K040090
Pneupac , Ltd.
Anesthesiology · 132d
Cleared Mar 26, 2004
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K032386
Impact Instrumentation, Inc.
Anesthesiology · 235d
Cleared Sep 29, 2003
PARAPAC 200D TRANSPORT, MODEL V200D
K030803
Pneupac , Ltd.
Anesthesiology · 200d
Cleared Jul 17, 2003
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
K021841
Pneupac , Ltd.
Anesthesiology · 407d
Cleared Dec 13, 2002
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
K020899
Pneupac , Ltd.
Anesthesiology · 268d
Cleared Jul 15, 2002
EMT-CPAP
K021520
Emergency Medical Techology
Anesthesiology · 66d