510(k) K081266

MERCURY MEDICAL PEEP VALVE by Mercury Enterprizes Dba Mercury Medical — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2009
Date Received
May 5, 2008
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