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510(k) K201208

Halo AF Detection System by Livmor — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2020
Date Received
May 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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