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510(k) K172311

BioFlux Device by Biotricity, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2017
Date Received
August 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

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