ECG SENTINEL System— 510(k) K172801

Substantially Equivalent

Cardiomedix, Inc.

FDA 510(k) clearance K172801 for ECG SENTINEL System, Substantially Equivalent on 2017-10-18. Applicant: Cardiomedix, Inc..

Clearance details

Applicant: Cardiomedix, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2017-09-18
Decision date: 2017-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evanston, IL, US

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