510(k) K935213

INCONTROL by Thought Technology , Ltd. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1995
Date Received
October 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type