ECG CHECK— 510(k) K122184

Substantially Equivalent

Cardiac Designs, LLC

FDA 510(k) clearance K122184 for ECG CHECK, Substantially Equivalent on 2013-02-14. Applicant: Cardiac Designs, LLC.

Clearance details

Applicant: Cardiac Designs, LLC
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2012-07-23
Decision date: 2013-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, US

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