510(k) K921062

GAELTEC MPR SERIES by Medical Measurements, Inc. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
March 5, 1992
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