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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hypertension Machine Learning-Based Notification Software
510(k) Number K250507
Device Name Hypertension Notification Feature (HTNF)
Applicant
Apple Inc.
One Apple Park Way
Cupertino,  CA  95014
Applicant Contact Bonnie Wu
Correspondent
Apple Inc.
One Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Bonnie Wu
Classification Product Code
SFR  
Date Received02/21/2025
Decision Date 09/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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