HeartCheck Cardi Beat ECG Monitor with GEMS Mobile— 510(k) K181310

Substantially Equivalent

Cardiocomm Solutions, Inc.

FDA 510(k) clearance K181310 for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile, Substantially Equivalent on 2019-02-22. Applicant: Cardiocomm Solutions, Inc..

Clearance details

Applicant: Cardiocomm Solutions, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2018-05-17
Decision date: 2019-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North York, CA

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