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510(k) K143512

ActiSpec Activity Monitor by Sleep Modus, Inc. — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2015
Date Received
December 11, 2014
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

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