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
49–72 of 210
Cleared Sep 13, 1999
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
K992057
Sims Portex, Inc.
Anesthesiology · 87d
Cleared Jul 06, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K991955
Engineered Medical Systems
Anesthesiology · 35d
Cleared Jul 01, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K991953
Engineered Medical Systems
Anesthesiology · 30d
Cleared Sep 18, 1998
MANUAL RESUSCITATOR WITH ACE
K982215
Medical Marketing Concepts
Anesthesiology · 87d
Cleared Jul 16, 1998
CPR FILTERSHIELD
K980066
Plasco, Inc.
Anesthesiology · 190d
Cleared Jul 06, 1998
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
K981307
International Respiratory Systems, Inc.
Anesthesiology · 87d
Cleared Jul 06, 1998
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
K981308
International Respiratory Systems, Inc.
Anesthesiology · 87d
Cleared May 21, 1998
PLUS REUSABLE RESUSCITATOR
K974141
Schiff & Co.
Anesthesiology · 199d
Cleared Mar 25, 1998
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K973419
Nellcor Puritan Bennett, Inc.
Anesthesiology · 196d
Cleared Jan 29, 1998
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K973106
Allied Healthcare Products, Inc.
Anesthesiology · 163d
Cleared Dec 02, 1997
OHMEDA INFANT RESUSCITATION SYSTEM
K971243
Ohmeda Medical
Anesthesiology · 243d
Cleared Oct 31, 1997
MERCURY MEDICAL REUSABLE CPR BAG
K970756
Mercury Medical
Anesthesiology · 242d
Cleared Sep 17, 1997
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
K972283
Sims
Anesthesiology · 90d
Cleared Sep 03, 1997
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
K972139
Davis & Geck, Inc.
Anesthesiology · 89d
Cleared Jul 07, 1997
MANUAL RESUSCITATOR
K963848
Owens-Brigam Medical Co.
Anesthesiology · 285d
Cleared Jun 16, 1997
DATEX ENGSTOM MANUAL RESUSCITATOR
K970991
Promedic, Inc.
Anesthesiology · 89d
Cleared Jun 13, 1997
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959
Instrumentation Industries, Inc.
Anesthesiology · 88d
Cleared May 15, 1997
AMBU SPUR NEONATE
K964584
Ambu, Inc.
Anesthesiology · 181d
Cleared Feb 21, 1997
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
K964719
Hudson Respiratory Care, Inc.
Anesthesiology · 88d
Cleared Aug 15, 1996
GRAYCO POCKET PUMP
K955507
Grayco, Inc.
Anesthesiology · 258d
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