510(k) K981415

0-20 CM H20 PEEP VALVE by Cheen Houng Ent. Co. , Ltd. — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1998
Date Received
April 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type