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
193–210 of 210
Cleared Jan 21, 1983
DISPOSABLE AIRWAY ADEJUNCT
K823710
Groves Medical Supply, Inc.
Anesthesiology · 43d
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 20, 1982
MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
K822356
Laerdal Medical Corp.
Anesthesiology · 14d
Cleared Mar 26, 1982
RESUSCITATION MASK
K820059
Cederroth, Inc. USA
Anesthesiology · 74d
Cleared Aug 25, 1981
RESUSCITATION CIRCUIT
K812273
Vital Signs, Inc.
Anesthesiology · 12d
Cleared Jul 31, 1981
ZEE MANUAL RESUSCITATOR
K812022
Zee Medical Products Co., Inc.
Anesthesiology · 11d
Cleared Feb 12, 1981
DISPOSABLE BAG MASK ADEJUNCT
K803066
T. S. Enterprises, Inc.
Anesthesiology · 70d
Cleared Dec 17, 1980
PMR-2 PURITAN MANUAL RESUSCITATOR
K802813
Puritan Bennett Corp.
Anesthesiology · 40d
Cleared Oct 10, 1980
AIR VIVA II
K802231
General Medical Co.
Anesthesiology · 25d
Cleared Sep 26, 1980
AULD BAGGER KIT
K802081
Modern Medical Systems Co.
Anesthesiology · 29d
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
Cleared Aug 02, 1977
RESUSCITATOR, MS30
K771175
Mckesson Corp.
Anesthesiology · 34d
Cleared Jan 26, 1977
NEONATAL RESUSCITATOR, SAMSON
K761065
Dem Medical, Inc.
Anesthesiology · 69d
Cleared Nov 24, 1976
BAG RESUSCITATOR
K761025
Robert Shaw Controls Co.
Anesthesiology · 12d