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
73–96 of 210
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 Dec 20, 1995
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
K954150
Green Field Medical Sourcing, Inc.
Anesthesiology · 106d
Cleared Dec 20, 1995
BAGRIGHT RESUSCITATOR
K954296
Medical Marketing Concepts
Anesthesiology · 97d
Cleared Nov 22, 1995
RESPOSABLE RESUSCITATOR
K953617
Medical Marketing Concepts
Anesthesiology · 111d
Cleared Sep 19, 1995
LIFEMASK FACE SHIELD
K953824
Carefree Trading, Inc.
Anesthesiology · 35d
Cleared Aug 28, 1995
CAPNO-FLO REGULATOR, CAPNO-FLO
K952512
Kirk Specialty Systems
Anesthesiology · 90d
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 21, 1994
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380
K944301
Hudson Respiratory Care, Inc.
Anesthesiology · 106d
Cleared Dec 12, 1994
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K944347
Puritan Bennett Corp.
Anesthesiology · 97d
Cleared Oct 28, 1994
MATRX HOPE(R) 5 RESUSCITATOR
K921982
Matrix Medica, Inc.
Anesthesiology · 913d
Cleared Aug 18, 1994
BNOS MICRO VENT, MODEL AC AND MODEL AO
K941037
Reeves Manufactoring
Anesthesiology · 169d
Cleared Aug 11, 1994
DISPOSABLE MANUAL RESUSCITATOR
K943617
Puritan-Bennett
Anesthesiology · 15d
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 Oct 06, 1993
CAPNO-FLO
K933626
Kirk Specialty Systems
Anesthesiology · 82d
Cleared Sep 03, 1993
PRESSURE LIMITING ELBOW
K932797
Engineered Medical Systems
Anesthesiology · 86d