BTL · Class II · 21 CFR 868.5925

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

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

100
Total
100
Cleared
156d
Avg days
1977
Since
100 devices
73–96 of 100
Cleared Jan 19, 1988
AUTOMATIC VENTILATOR AV2000
K874656
Life Support Products, Inc.
Anesthesiology · 61d
Cleared Jan 12, 1987
PATIENT VALVE WITH AIR ENTRAINMENT
K863410
Pneupac , Ltd.
Anesthesiology · 173d
Cleared Oct 15, 1986
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR
K862830
Pneupac , Ltd.
Anesthesiology · 84d
Cleared May 20, 1986
IMPACT MODELS 701, 702 AND 703
K861272
Impact Instrumentation, Inc.
Anesthesiology · 46d
Cleared Feb 18, 1986
SG-066 OXYGEN ENRICHMENT KIT
K860077
Instrumentation Industries, Inc.
Anesthesiology · 41d
Cleared May 15, 1985
502 RESUSCITATORY INHALATOR VALVE
K851337
Life Support Products, Inc.
Anesthesiology · 42d
Cleared Feb 05, 1980
PNEUPAC OXYGEN THERAPY UNIT
K792453
Pneupac , Ltd.
Anesthesiology · 64d