ECG Check - Universal, ECG Check - Universal Plus— 510(k) K170506

Substantially Equivalent

Cardiac Designs, Inc.

FDA 510(k) clearance K170506 for ECG Check - Universal, ECG Check - Universal Plus, Substantially Equivalent on 2017-10-02. Applicant: Cardiac Designs, Inc..

Clearance details

Applicant: Cardiac Designs, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2017-02-21
Decision date: 2017-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spring, TX, US

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