Hypertension Machine Learning-Based Notification Software
FDA product code SFR · Class II (moderate risk) · 21 CFR 870.2380 · Cardiovascular
Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250507 | Hypertension Notification Feature (HTNF)SFR · Traditional | Apple, Inc. | 09/11/2025SE |