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Informational only. Not affiliated with any government agency. Verify details at the official source.

Devices

Apple Inc.

5 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.

DateSubmissionDevicePanelCode
September 11, 2025K250507Hypertension Notification Feature (HTNF)CardiovascularSFR
September 13, 2024K240929Sleep Apnea Notification Feature (SANF)AnesthesiologyQZW
July 21, 2023K231173Irregular Rhythm Notification Feature (IRNF)CardiovascularQDB
June 3, 2022K213971Atrial Fibrillation History FeatureCardiovascularQDB
October 22, 2021K212516IRNF AppCardiovascularQDB