BTL · Class II · 21 CFR 868.5925

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

Leading manufacturers include Allied Healthcare Products, Inc., Vortran Medical Technology 1, Inc. and Impact Instrumentation, Inc..

100
Total
100
Cleared
156d
Avg days
1977
Since
100 devices
25–48 of 100
Cleared Dec 30, 1994
IMPACT MODEL 753
K931473
Impact Instrumentation, Inc.
Anesthesiology · 646d
Cleared Jan 12, 1993
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910
J. H. Emerson Co.
Anesthesiology · 320d
Cleared May 28, 1991
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920
Ambu, Inc.
Anesthesiology · 209d
Cleared Dec 27, 1990
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697
Impact Instrumentation, Inc.
Anesthesiology · 3d
Cleared Aug 08, 1990
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846
Ohmeda Medical
Anesthesiology · 106d
Cleared Jan 09, 1990
BIVONA CARDEN INTERMITTENT JETTING DEVICE
K895946
Bivona Medical Technologies
Anesthesiology · 90d
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