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
121–144 of 210
Cleared Aug 02, 1991
MOUTH TO MASK RESUSCITATOR
K912625
Vital Signs, Inc.
Anesthesiology · 50d
Cleared Jul 24, 1991
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
K904899
Vital Signs, Inc.
Anesthesiology · 267d
Cleared Jun 25, 1991
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
K911298
Intertech Resources, Inc.
Anesthesiology · 92d
Cleared Jun 18, 1991
MANUAL RESUSCITATOR
K910856
Vital Signs, Inc.
Anesthesiology · 110d
Cleared May 28, 1991
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
K910040
Ambu, Inc.
Anesthesiology · 144d
Cleared May 20, 1991
CPR BAG
K911622
Merced Medical, Inc.
Anesthesiology · 39d
Cleared Apr 17, 1991
DRESSER ARGUS P/N 1818
K905304
Dresser Argus, Inc.
Anesthesiology · 140d
Cleared Mar 29, 1991
SINGLE USE MANUAL RESUSCITATORS
K905002
Custom Medical, Inc.
Anesthesiology · 142d
Cleared Oct 02, 1990
BAUMAN CPR/RESUSCITATOR
K904346
General Medical Products, Inc.
Anesthesiology · 8d
Cleared Aug 22, 1990
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
K902733
Intertech Resources, Inc.
Anesthesiology · 62d
Cleared Aug 17, 1990
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
K903438
Puritan Bennett Corp.
Anesthesiology · 17d
Cleared Aug 17, 1990
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
K903443
Puritan Bennett Corp.
Anesthesiology · 17d
Cleared Aug 17, 1990
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
K903570
Puritan Bennett Corp.
Anesthesiology · 10d
Cleared Aug 17, 1990
INFANT MANUAL RESUSCITATOR (PMR 2)
K903631
Puritan Bennett Corp.
Anesthesiology · 7d
Cleared Jul 16, 1990
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
K900577
Intertech Resources, Inc.
Anesthesiology · 159d
Cleared Jul 16, 1990
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
K902261
Ambu, Inc.
Anesthesiology · 56d
Cleared Jun 08, 1990
AMBU LIFE KEY AND AMBU RES-CUE KEY
K900260
Ambu, Inc.
Anesthesiology · 142d
Cleared May 18, 1990
LIFE AID RESUSCITATOR
K901218
Clarendon Supplies , Ltd.
Anesthesiology · 65d
Cleared May 01, 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349
Puritan Bennett Corp.
Anesthesiology · 97d
Cleared Apr 04, 1990
RESUSO MASK
K895820
Rml Ent., Inc.
Anesthesiology · 190d
Cleared Mar 30, 1990
MANUAL RESUSCITATOR
K895589
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 196d
Cleared Feb 06, 1990
ARTEC RESPOND PULMONARY RESUSCITATOR
K896886
Artec Environmental Monitoring Division
Anesthesiology · 60d
Cleared Oct 27, 1989
RESPIRONICS INFANT BAGEASY
K895351
Respironics, Inc.
Anesthesiology · 56d
Cleared Oct 13, 1989
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
K895169
F.L.W. Plastics, Inc.
Anesthesiology · 64d