510(k) K250507

Hypertension Notification Feature (HTNF) by Apple, Inc. — Product Code SFR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 11, 2025
Date Received: February 21, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hypertension Machine Learning-Based Notification Software
Device Class: Class II
Regulation Number: 870.2380
Review Panel: CV
Submission Type

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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