IRNF App— 510(k) K212516

Substantially Equivalent

Apple, Inc.

FDA 510(k) clearance K212516 for IRNF App, Substantially Equivalent on 2021-10-22. Applicant: Apple, Inc..

Clearance details

Applicant: Apple, Inc.
Product code: Code QDB
Advisory panel: Cardiovascular
Date received: 2021-08-10
Decision date: 2021-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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