510(k) K250507

Device

Hypertension Notification Feature (HTNF)

Applicant

Apple, Inc.

510(k) number

K250507

Product code

SFR

Decision

Substantially Equivalent (SESE)

Decision date

2025-09-11

Date received

2025-02-21

Regulation

870.2380

Classification name

Hypertension Machine Learning-Based Notification Software

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No