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.

209
Total
209
Cleared
124d
Avg days
1976
Since
209 devices
97–120 of 209
Cleared Jun 08, 1990
AMBU LIFE KEY AND AMBU RES-CUE KEY
K900260
Ambu, Inc.
Anesthesiology · 142d
Cleared May 01, 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349
Puritan Bennett Corp.
Anesthesiology · 97d
Cleared Mar 30, 1990
MANUAL RESUSCITATOR
K895589
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 196d
Cleared Oct 27, 1989
RESPIRONICS INFANT BAGEASY
K895351
Respironics, Inc.
Anesthesiology · 56d
Cleared Oct 06, 1989
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K894365
Puritan Bennett Corp.
Anesthesiology · 84d
Cleared May 18, 1989
PULMONARY RESUSCITATOR, MODIFICATION
K892221
Life Design Systems, Inc.
Anesthesiology · 49d
Cleared Nov 16, 1988
PULMANEX TM (NEO-NATAL SIZE)
K884068
Life Design Systems, Inc.
Anesthesiology · 78d
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 Jan 22, 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418
Life Support Products, Inc.
Anesthesiology · 86d
Cleared Oct 26, 1987
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K873286
Hospitak, Inc.
Anesthesiology · 70d
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 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 Sep 27, 1984
FLOW CONTROLLER
K843223
Precision Medical, Inc.
Anesthesiology · 42d
Cleared Aug 10, 1984
RESPIRONICS VENTEASY
K842693
Respironics, Inc.
Anesthesiology · 30d
Cleared Jul 06, 1984
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
K842487
J. H. Emerson Co.
Anesthesiology · 10d
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 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