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510(k) K130971

OPTUM TELEHEALTH APPLICATION by Optumhealth Care Solutions, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2013
Date Received
April 8, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

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