510(k) K132764

MOTION WATCH AND PRO-DIARY by Camntech, Ltd. — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2014
Date Received
September 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type