Apple, Inc.
Medical device manufacturer in Cupertino, CA.
9510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF)SHN · Traditional | 04/01/2026SE |
| K250507 | Hypertension Notification Feature (HTNF)SFR · Traditional | 09/11/2025SE |
| K250143 | Digital Prism Correction Feature (DPCF)SCW · Traditional | 06/23/2025SE |
| K242058 | Digital Prism Correction Feature (DPCF)SCW · Traditional | 10/21/2024SE |
| K240929 | Sleep Apnea Notification Feature (SANF)QZW · Traditional | 09/13/2024SE |
| K231173 | Irregular Rhythm Notification Feature (IRNF)QDB · Traditional | 07/21/2023SE |
| K213971 | Atrial Fibrillation History FeatureQDB · Traditional | 06/03/2022SE |
| K212516 | IRNF AppQDB · Traditional | 10/22/2021SE |
| K201525 | ECG AppQDA · Traditional | 10/08/2020SE |