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
49–72 of 209
Cleared Jul 02, 1996
BAGRIGHT CHILD RESUSCITATOR
K961329
Medical Marketing Concepts
Anesthesiology · 85d
Cleared Jul 02, 1996
BAGRIGHT INFANT RESUSCITATOR
K961330
Medical Marketing Concepts
Anesthesiology · 85d
Cleared Jun 28, 1996
BAGRIGHT RESPOSABLE CHILD RESUSCITATOR
K961331
Medical Marketing Concepts
Anesthesiology · 81d
Cleared Jun 28, 1996
BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
K961332
Medical Marketing Concepts
Anesthesiology · 81d
Cleared Jun 28, 1996
BAGRIGHT RESPOSABLE RESUSCITATOR
K961369
Medical Marketing Concepts
Anesthesiology · 80d
Cleared Jun 28, 1996
RESPOSABLE CHILD RESUSCITATOR
K961868
Medical Marketing Concepts
Anesthesiology · 44d
Cleared Jun 28, 1996
RESPOSABLE INFANT RESUSCITATOR
K961882
Medical Marketing Concepts
Anesthesiology · 44d
Cleared Apr 26, 1996
DMR/CO2 COMBO KTI
K960468
Nellcor Puritan Bennett, Inc.
Anesthesiology · 85d
Cleared Feb 29, 1996
MANUAL PULMONARY RESUSICITATOR
K953546
Medical Marketing Concepts
Anesthesiology · 216d
Cleared Jan 30, 1996
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
K954866
Mercury Medical
Anesthesiology · 98d
Cleared Jun 08, 1995
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
K952169
Intertech Resources, Inc.
Anesthesiology · 31d
Cleared Jan 05, 1995
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699
Respironics, Inc.
Anesthesiology · 462d
Cleared Dec 12, 1994
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K944347
Puritan Bennett Corp.
Anesthesiology · 97d
Cleared May 06, 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581
Respironics, Inc.
Anesthesiology · 87d
Cleared Dec 14, 1993
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310
Respironics, Inc.
Anesthesiology · 104d
Cleared Nov 24, 1993
LSP (MODEL 554) BAG MASK RESUSCITATOR
K922691
Life Support Products, Inc.
Anesthesiology · 538d
Cleared Nov 24, 1993
INFANT DISPOSABLE BAG MASK RESUSCITATOR
K922819
Life Support Products, Inc.
Anesthesiology · 531d
Cleared Sep 03, 1993
PRESSURE LIMITING ELBOW
K932797
Engineered Medical Systems
Anesthesiology · 86d
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 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