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
145–168 of 210
Cleared Oct 06, 1989
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K894365
Puritan Bennett Corp.
Anesthesiology · 84d
Cleared Jul 24, 1989
NEOVO2R VENTILATORY
K885243
Neomed
Anesthesiology · 214d
Cleared May 18, 1989
PULMONARY RESUSCITATOR, MODIFICATION
K892221
Life Design Systems, Inc.
Anesthesiology · 49d
Cleared Feb 17, 1989
OXYGENATION CATHETER
K881881
Ventech Healthcare Corp., Inc.
Anesthesiology · 289d
Cleared Dec 16, 1988
AIRWAY-CIRCULATION EVALUATOR
K881483
Resuscitation Ace, Inc.
Anesthesiology · 252d
Cleared Nov 16, 1988
PULMANEX TM (NEO-NATAL SIZE)
K884068
Life Design Systems, Inc.
Anesthesiology · 78d
Cleared Nov 16, 1988
ADULT RESUSCITATOR WITH MASK AND FILTER
K884526
Intertech/Ohio
Anesthesiology · 20d
Cleared Sep 14, 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434
Ambu, Inc.
Anesthesiology · 30d
Cleared Aug 16, 1988
NONREBREATHING CIRCUIT
K882285
Dryden Corp.
Anesthesiology · 76d
Cleared Aug 15, 1988
RES-Q 1, 2, 3, 4 AND 5
K881207
Nova-Ventrx
Anesthesiology · 147d
Cleared Jun 23, 1988
CPR BAG
K881686
Devolve Corp.
Anesthesiology · 65d
Cleared Jun 16, 1988
RESUSCITATION BAG CONTROLLER (RBC)
K882278
Physician Engineered Products, Inc.
Anesthesiology · 15d
Cleared Apr 14, 1988
LIFEGUARD MOUTH TO MASK RESUSCITATOR
K881086
Lifeguard Medical Products, Inc.
Anesthesiology · 31d
Cleared Apr 14, 1988
LIFEGUARD SINGLE USE MANUAL RESUSCITATORS
K881087
Lifeguard Medical Products, Inc.
Anesthesiology · 31d
Cleared Mar 04, 1988
RESUSCI PATIENT FACE SHIELD
K880450
Laerdal Medical Corp.
Anesthesiology · 31d
Cleared Feb 29, 1988
RESUSCITATOR
K874567
American Medical Technology, Inc.
Anesthesiology · 116d
Cleared Feb 29, 1988
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
K880394
Intertech/Ohio
Anesthesiology · 31d
Cleared Jan 22, 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418
Life Support Products, Inc.
Anesthesiology · 86d
Cleared Jan 19, 1988
SOLCO SILICONE RESUSCITATOR
K874321
Kahn-Tact U.S.A., Inc.
Anesthesiology · 90d
Cleared Jan 19, 1988
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
K875077
Herco Products, Inc.
Anesthesiology · 41d
Cleared Oct 26, 1987
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K873286
Hospitak, Inc.
Anesthesiology · 70d
Cleared Sep 28, 1987
MOUTH TO FACE RESUSCITATOR
K873043
Artec Environmental Monitoring Division
Anesthesiology · 55d
Cleared Apr 20, 1987
MODIFIED CPREVIVER
K871147
Augerscope, Inc.
Anesthesiology · 39d
Cleared Mar 09, 1987
BAUMAN CPR/RESPIRATOR
K864308
General Medical Products, Inc.
Anesthesiology · 126d