510(k) K913736

DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST by Biosearch Medical Products, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1992
Date Received
August 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type