BTM · Class II · 21 CFR 868.5915

FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)

Leading manufacturers include Ambu, Inc., Puritan Bennett Corp. and Medical Marketing Concepts.

210
Total
210
Cleared
123d
Avg days
1976
Since
210 devices
169–192 of 210
Cleared Feb 26, 1987
CPREVIVER
K864125
Augerscope, Inc.
Anesthesiology · 128d
Cleared Aug 26, 1986
PULMANEX TM (MODIFICATION)
K863026
Life Design Systems, Inc.
Anesthesiology · 15d
Cleared Mar 27, 1986
PULMANEX (TM)
K860693
Life Design Systems, Inc.
Anesthesiology · 30d
Cleared Mar 06, 1986
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
K860180
Life Support Products, Inc.
Anesthesiology · 44d
Cleared Nov 01, 1985
PULMANEX
K854037
Life Design Systems, Inc.
Anesthesiology · 51d
Cleared Sep 06, 1985
COMBIBAG MANUAL RESUSCITATOR
K851171
Frontline Medical Corp.
Anesthesiology · 168d
Cleared Jul 08, 1985
RESUS-AID DISPOSABLE RESUSCITATION SHIELD
K852096
Emergency Situation Products
Anesthesiology · 55d
Cleared Mar 25, 1985
RESUSCITATOR, PULMONARY, MANUAL
K844729
Life Design Systems, Inc.
Anesthesiology · 111d
Cleared Feb 26, 1985
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436
Vital Signs, Inc.
Anesthesiology · 21d
Cleared Dec 17, 1984
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
K844420
Med-Life, Inc.
Anesthesiology · 32d
Cleared Sep 27, 1984
FLOW CONTROLLER
K843223
Precision Medical, Inc.
Anesthesiology · 42d
Cleared Aug 10, 1984
RESPIRONICS VENTEASY
K842693
Respironics, Inc.
Anesthesiology · 30d
Cleared Jul 27, 1984
LIFE-MASK INFANT RESUSCITATOR
K842696
Electronic Monitors, Inc.
Anesthesiology · 16d
Cleared Jul 06, 1984
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
K842487
J. H. Emerson Co.
Anesthesiology · 10d
Cleared Apr 24, 1984
FRASER HARLAKE HOPE III RESUSCITATOR
K841496
Fraser Harlake, Inc.
Anesthesiology · 14d
Cleared Apr 05, 1984
MANUAL RESUSCITATION SYSTEM
K840935
Inspiron Corp.
Anesthesiology · 31d
Cleared Feb 10, 1984
MARK III RESUSCITATOR
K840349
Ambu, Inc.
Anesthesiology · 15d
Cleared Jan 18, 1984
RESCUE MASK
K834250
Rondex Products, Inc.
Anesthesiology · 42d
Cleared Jan 13, 1984
FLYNN III-CHILD BAG-MASK UNIT ETC
K834400
O-Two Systems Intl., Inc.
Anesthesiology · 30d
Cleared Nov 29, 1983
REVIVE
K833244
Aladdin Industries, Inc.
Anesthesiology · 70d
Cleared Sep 29, 1983
FLYNN SERIES III BAG/MASK UNIT-
K832495
O-Two Systems Intl., Inc.
Anesthesiology · 64d
Cleared Sep 08, 1983
CODE BLUE MANUAL RESUSCITATOR
K831885
Vital Signs, Inc.
Anesthesiology · 87d
Cleared Aug 12, 1983
SC-603 TWIN VALVE
K831486
Instrumentation Industries, Inc.
Anesthesiology · 94d
Cleared Jun 24, 1983
CPR HEARTSAVER AND BREATHOLATOR
K831198
Cervco Corp.
Anesthesiology · 73d