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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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RecordFirmDate
Hypertension Notification Feature (HTNF) (K250507)Apple, Inc.2025-09-11

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