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510(k) K080545

ACTITRAINER by Actigraph, LLC — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2008
Date Received
February 27, 2008
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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