510(k) K905154

GASTROSCAN by Medics Instrument Corp. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1991
Date Received
November 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type