ECordum Cardiac Monitor (eCordum CM)

Transmitters And Receivers, Electrocardiograph, Telephone

ECordum, Inc.

The following data is part of a premarket notification filed by Ecordum, Inc. with the FDA for Ecordum Cardiac Monitor (ecordum Cm).

Pre-market Notification Details

Device IDK193296
510k NumberK193296
Device Name:ECordum Cardiac Monitor (eCordum CM)
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant eCordum, Inc. 419 1st Street East Northport,  NY  11731
ContactVladislav Bukhman
CorrespondentBecky Ditty
Biologics Consulting 1555 King St, Suite 300 Alexandria,  VA  22314
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-27
Decision Date2020-10-30

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