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
121–144 of 209
Cleared Dec 07, 1982
BE#1000-INSTANT ON/OFF O2 VALVE
K823408
Instrumentation Industries, Inc.
Anesthesiology · 22d
Cleared Oct 28, 1982
SIEMENS-ELEMA AB AGA REVIVATOR
K822213
Siemens Elema AB
Anesthesiology · 94d
Cleared Aug 25, 1981
RESUSCITATION CIRCUIT
K812273
Vital Signs, Inc.
Anesthesiology · 12d
Cleared Dec 17, 1980
PMR-2 PURITAN MANUAL RESUSCITATOR
K802813
Puritan Bennett Corp.
Anesthesiology · 40d
Cleared Nov 13, 1979
AIR-SHIELDS RESUSCITATORS
K792118
Narco Air-Shields
Anesthesiology · 18d
Cleared Aug 22, 1979
RESUSCI-BAG-VALVE
K791468
Concept, Inc.
Anesthesiology · 16d
Cleared Mar 14, 1978
LIFESAVER, MANUAL #5160
K780216
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 32d
Cleared Aug 19, 1977
AMBU RESUSCITATOR
K771350
Air-Shields, Inc.
Anesthesiology · 29d