BYE · Class II · 21 CFR 868.5965

FDA Product Code BYE: Attachment, Breathing, Positive End Expiratory Pressure

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

80
Total
80
Cleared
93d
Avg days
1976
Since
80 devices
49–72 of 80
Cleared Jul 16, 1987
RESPIRONICS SANDERS BIPAPEASY
K871523
Respironics, Inc.
Anesthesiology · 87d
Cleared Jul 14, 1986
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
K861758
Life Design Systems, Inc.
Anesthesiology · 69d
Cleared Feb 24, 1986
LDS PEEP VALVE
K854822
Life Design Systems, Inc.
Anesthesiology · 83d
Cleared Jan 15, 1986
CUSHION-FLEX TM-CPAP FACE MASK
K854458
Life Design Systems, Inc.
Anesthesiology · 70d
Cleared May 15, 1985
SANDER'S MASKCPAP BY RESPIRONICS
K851396
Respironics, Inc.
Anesthesiology · 36d
Cleared Apr 15, 1985
AMBU CPAP SYSTEM
K851194
Ambu, Inc.
Anesthesiology · 20d
Cleared Dec 04, 1984
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889
Respironics, Inc.
Anesthesiology · 63d
Cleared Nov 15, 1984
OHMEDA PEEP VALVE FOR GMS ABSORBER
K843835
Ohmeda Medical
Anesthesiology · 45d
Cleared Dec 16, 1983
DRAGER PEEP SYSTEM D
K834085
Draeger Medical, Inc.
Anesthesiology · 17d
Cleared Sep 12, 1983
DOWNS ADJUSTABLE FLOW GENERATOR
K831503
Vital Signs, Inc.
Anesthesiology · 124d
Cleared Jun 08, 1983
PEEP SYSTEM D
K831301
Draeger Medical, Inc.
Anesthesiology · 48d
Cleared Mar 01, 1982
PEEP VALVE
K820404
Vital Signs, Inc.
Anesthesiology · 17d
Cleared Nov 12, 1980
DRAGER PEEP CONTROL SYSTEM
K802707
Draeger Medical, Inc.
Anesthesiology · 12d
Cleared Sep 09, 1980
VITAL SIGNS PEEP VALVE
K802070
Vital Signs, Inc.
Anesthesiology · 13d
Cleared May 08, 1980
BOEHRINGER LABS AMBULATORY PEEP VALVE
K800755
Boehringer Laboratories
Anesthesiology · 34d
Cleared Dec 26, 1978
VALVE, AMBU PEEP
K782152
Narco Air-Shields
Anesthesiology
Cleared Oct 04, 1978
PEEP/CPAP VALVE
K781332
Vickers America Medical Corp.
Anesthesiology · 63d
Cleared Aug 06, 1976
VALVE, PEEP
K760230
Ohio Medical Products
Anesthesiology · 23d