BTM · Class II · 21 CFR 868.5915

FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)

Leading manufacturers include Puritan Bennett Corp., Vital Signs, Inc. and Respironics, Inc..

209
Total
209
Cleared
124d
Avg days
1976
Since
209 devices
25–48 of 209
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 18, 1991
MANUAL RESUSCITATOR
K910856
Vital Signs, Inc.
Anesthesiology · 110d
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 May 01, 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349
Puritan Bennett Corp.
Anesthesiology · 97d
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 Feb 26, 1985
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436
Vital Signs, Inc.
Anesthesiology · 21d
Cleared Aug 10, 1984
RESPIRONICS VENTEASY
K842693
Respironics, Inc.
Anesthesiology · 30d
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
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 Aug 22, 1979
RESUSCI-BAG-VALVE
K791468
Concept, Inc.
Anesthesiology · 16d