DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Ecordum, Inc.
Product code
Code DXH
Device class
Class 2
Regulation
21 CFR 870.2920
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
East Northport, NY, US
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