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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K193296
Device Name eCordum Cardiac Monitor (eCordum CM)
Applicant
Ecordum, Inc.
419 1st St.
East Northport,  NY  11731
Applicant Contact Vladislav Bukhman
Correspondent
Biologics Consulting
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Becky Ditty
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DSI  
Date Received11/27/2019
Decision Date 10/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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