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
97–120 of 210
Cleared Apr 21, 1993
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT
K924671
Engineered Medical Systems
Anesthesiology · 217d
Cleared Apr 06, 1993
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
K924610
Engineered Medical Systems
Anesthesiology · 207d
Cleared Mar 11, 1993
AID, CARDIOPULMONARY RESUSCITATION
K930429
Valley Forge Scientific Corp.
Anesthesiology · 44d
Cleared Feb 05, 1993
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
K923762
Ambu, Inc.
Anesthesiology · 192d
Cleared Feb 03, 1993
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
K913474
Med-Tek Innovations, Inc.
Anesthesiology · 548d
Cleared Jan 22, 1993
ODYSSEY
K922810
O-Two Systems Intl., Inc.
Anesthesiology · 226d
Cleared Dec 01, 1992
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
K913714
Life Design Systems, Inc.
Anesthesiology · 474d
Cleared Oct 19, 1992
LSPI INFANT BAG MASK
K921553
Life Support Products, Inc.
Anesthesiology · 201d
Cleared Oct 06, 1992
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
K921002
Rondex Products, Inc.
Anesthesiology · 224d
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 Mar 09, 1992
MER BAG
K915810
Merced Medical, Inc.
Anesthesiology · 76d
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 Dec 04, 1991
OPOMAT MANUAL RESUSCITATOR VENTILATOR
K912620
Euro-Am Pharma, Inc.
Anesthesiology · 174d
Cleared Nov 13, 1991
EMS SINGLE USE MANUAL RESUSCITATORS
K912203
Engineered Medical Systems
Anesthesiology · 177d
Cleared Nov 08, 1991
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
K914196
Rondex Products, Inc.
Anesthesiology · 64d
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