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510(k) K181077

ActiGraph CentrePoint Insight Watch by Actigraph — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2018
Date Received
April 24, 2018
Clearance Type
Special
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

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