ECG App— 510(k) K201525

Substantially Equivalent

Apple, Inc.

FDA 510(k) clearance K201525 for ECG App, Substantially Equivalent on 2020-10-08. Applicant: Apple, Inc..

Clearance details

Applicant: Apple, Inc.
Product code: Code QDA
Advisory panel: Cardiovascular
Date received: 2020-06-08
Decision date: 2020-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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