SFR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hypertension Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Medical specialty
- Cardiovascular
- FDA definition
- Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.
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| Record | Firm | Date |
|---|---|---|
| Hypertension Notification Feature (HTNF) (K250507) | Apple, Inc. | 2025-09-11 |
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Every clearance here is in the API, with alerts when new ones post.