eCordum Cardiac Monitor (eCordum CM)— 510(k) K193296

Substantially Equivalent

Ecordum, Inc.

FDA 510(k) clearance K193296 for eCordum Cardiac Monitor (eCordum CM), Substantially Equivalent on 2020-10-30. Applicant: Ecordum, Inc..

Clearance details

Applicant: Ecordum, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2019-11-27
Decision date: 2020-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Northport, NY, US

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