ClearanceBrief
510(k) K250507 ยท SFR Hypertension Machine Learning-Based Notification Software

Hypertension Notification Feature (HTNF)

ApplicantApple, Inc., Cupertino CA, US
DecisionSubstantially Equivalent, Sep 11, 2025
ReceivedFeb 21, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250507

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.