K250507
- 510(k) number
- K250507
- Device name
- Hypertension Notification Feature (HTNF)
- Applicant
- Apple, Inc. CA · US
- Product code
- SFR — Hypertension Machine Learning-Based Notification Sof
- Decision date
- 2025-09-11
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K250507.pdf
Official FDA record: K250507
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.