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
49–72 of 100
Cleared Jul 05, 2000
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430
Vortran Medical Technology 1, Inc.
Anesthesiology · 61d
Cleared Aug 17, 1999
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785
Instrumentation Industries, Inc.
Anesthesiology · 84d
Cleared Apr 22, 1999
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
K991195
O-Two Systems Intl., Inc.
Anesthesiology · 14d
Cleared Nov 04, 1998
AUTOVENT 1500
K983857
O-Two Systems Intl., Inc.
Anesthesiology · 2d
Cleared Oct 29, 1998
GENESIS BLS
K983643
O-Two Systems Intl., Inc.
Anesthesiology · 13d
Cleared Oct 29, 1998
EMT RESUSCITATOR
K983705
O-Two Systems Intl., Inc.
Anesthesiology · 8d
Cleared Oct 29, 1998
AUTOVENT 1000
K983785
O-Two Systems Intl., Inc.
Anesthesiology · 2d
Cleared Oct 28, 1998
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
K982225
Spiracle Technology
Anesthesiology · 126d
Cleared Jun 12, 1998
RESPIRTECHPRO
K973975
Vortran Medical Technology 1, Inc.
Anesthesiology · 235d
Cleared Oct 10, 1996
PARAPAC
K960515
Pneupac , Ltd.
Anesthesiology · 248d
Cleared Mar 24, 1995
DRAGER MEDICAL AIR COMPRESSOR
K951126
Drager, Inc.
Anesthesiology · 11d
Cleared Jan 09, 1995
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
K941870
Life Support Products, Inc.
Anesthesiology · 266d
Cleared Jan 09, 1995
LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
K941871
Life Support Products, Inc.
Anesthesiology · 266d
Cleared Dec 30, 1994
IMPACT MODEL 753
K931473
Impact Instrumentation, Inc.
Anesthesiology · 646d
Cleared Nov 24, 1993
LSPI AUTOMATIC VENTILATOR, MODEL AV3000
K932199
Life Support Products, Inc.
Anesthesiology · 202d
Cleared Nov 24, 1993
LSPI AUTOMATIC VENTILATOR
K932200
Life Support Products, Inc.
Anesthesiology · 202d
Cleared Jan 12, 1993
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910
J. H. Emerson Co.
Anesthesiology · 320d
Cleared Jan 30, 1992
SPIROS
K915564
Life Support Products, Inc.
Anesthesiology · 49d
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 Oct 06, 1989
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
K892885
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 170d
Cleared Jan 22, 1988
LSP AUTOMATIC VENTILATOR, MODEL 456
K870424
Life Support Products, Inc.
Anesthesiology · 353d