BYE · Class II · 21 CFR 868.5965

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

Leading manufacturers include Respironics, Inc..

80
Total
80
Cleared
93d
Avg days
1976
Since

FDA 510(k) Cleared Attachment, Breathing, Positive End Expiratory Pressure Devices (Product Code BYE)

80 devices
1–24 of 80
Cleared Mar 28, 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113
Respironics, Inc.
Anesthesiology · 78d
Cleared Dec 08, 1988
MODIFIED SANDERS BI-PAPEASY
K883825
Respironics, Inc.
Anesthesiology · 90d
Cleared Jul 16, 1987
RESPIRONICS SANDERS BIPAPEASY
K871523
Respironics, Inc.
Anesthesiology · 87d
Cleared May 15, 1985
SANDER'S MASKCPAP BY RESPIRONICS
K851396
Respironics, Inc.
Anesthesiology · 36d
Cleared Dec 04, 1984
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889
Respironics, Inc.
Anesthesiology · 63d

About Product Code BYE - Regulatory Context