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510(k) K193296

eCordum Cardiac Monitor (eCordum CM) by Ecordum, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2020
Date Received
November 27, 2019
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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