FDA 510(k) Applications Submitted by Apple Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K231173 04/25/2023 Irregular Rhythm Notification Feature (IRNF) Apple Inc.
K212516 08/10/2021 IRNF App Apple Inc.
K250143 01/17/2025 Digital Prism Correction Feature (DPCF) Apple Inc.
K242058 07/15/2024 Digital Prism Correction Feature (DPCF) Apple Inc.
DEN230081 12/04/2023 Hearing Aid Feature (HAF) Apple Inc.
K201525 06/08/2020 ECG App Apple Inc.
K213971 12/20/2021 Atrial Fibrillation History Feature Apple Inc.
K240929 04/04/2024 Sleep Apnea Notification Feature (SANF) Apple Inc.


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