510(k) K962855

ULE-2, MULE-2, HAND ACCESSORY KIT by Penny and Giles Biometrics , Ltd. — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1996
Date Received
July 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type