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Apple, Inc.

12 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Medical Imaging Calibration Feature (MICF) (K253582)Apple, Inc.2026-04-01
Hypertension Notification Feature (HTNF) (K250507)Apple, Inc.2025-09-11
Digital Prism Correction Feature (DPCF) (K250143)Apple, Inc.2025-06-23
Digital Prism Correction Feature (DPCF) (K242058)Apple, Inc.2024-10-21
Sleep Apnea Notification Feature (SANF) (K240929)Apple, Inc.2024-09-13
Hearing Aid Feature (HAF) (DEN230081)Apple, Inc.2024-09-12
Irregular Rhythm Notification Feature (IRNF) (K231173)Apple, Inc.2023-07-21
Atrial Fibrillation History Feature (K213971)Apple, Inc.2022-06-03
IRNF App (K212516)Apple, Inc.2021-10-22
ECG App (K201525)Apple, Inc.2020-10-08
ECG App (DEN180044)Apple, Inc.2018-09-11
Irregular Rhythm Notification Feature (DEN180042)Apple, Inc.2018-09-11

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Every clearance here is in the API, with alerts when new ones post.