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
73–96 of 209
Cleared Sep 17, 1992
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
K924217
Life Support Products, Inc.
Anesthesiology · 29d
Cleared Sep 16, 1992
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
K924215
Ambu, Inc.
Anesthesiology · 43d
Cleared Sep 16, 1992
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
K924216
Ambu, Inc.
Anesthesiology · 43d
Cleared Jun 19, 1992
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
K922707
Ambu, Inc.
Anesthesiology · 14d
Cleared Jun 19, 1992
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
K922712
Ambu, Inc.
Anesthesiology · 14d
Cleared May 28, 1992
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004
Puritan Bennett Corp.
Anesthesiology · 29d
Cleared Feb 27, 1992
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K920570
Puritan Bennett Corp.
Anesthesiology · 20d
Cleared Jan 07, 1992
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
K913900
Ventlab Corp.
Anesthesiology · 130d
Cleared Nov 13, 1991
EMS SINGLE USE MANUAL RESUSCITATORS
K912203
Engineered Medical Systems
Anesthesiology · 177d
Cleared Oct 07, 1991
AMBU SILICONE RESUSCITATOR INFANT/CHILD
K914187
Ambu, Inc.
Anesthesiology · 19d
Cleared Aug 26, 1991
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370
Puritan Bennett Corp.
Anesthesiology · 28d
Cleared Aug 09, 1991
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K911971
Puritan Bennett Corp.
Anesthesiology · 98d
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 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