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FDA 510(k)

Hypertension Notification Feature (HTNF)

K-Number: K250507 · 2025-09-11

ApplicantApple, Inc.
Decision Date2025-09-11
Product CodeSFR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hypertension Notification Feature (HTNF) is a medical device manufactured by Apple, Inc.. It received FDA 510(k) clearance on 2025-09-11 under approval number K250507. The device is classified under product code SFR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypertension Notification Feature (HTNF)?

Hypertension Notification Feature (HTNF) is a medical device that received FDA 510(k) clearance on 2025-09-11. It is manufactured by Apple, Inc.. The 510(k) number is K250507.

When was Hypertension Notification Feature (HTNF) approved by the FDA?

Hypertension Notification Feature (HTNF) received FDA 510(k) clearance on 2025-09-11, under approval number K250507.

What company makes Hypertension Notification Feature (HTNF)?

Hypertension Notification Feature (HTNF) is manufactured by Apple, Inc..

What is the FDA product code for Hypertension Notification Feature (HTNF)?

The FDA product code for Hypertension Notification Feature (HTNF) is SFR.

Other Devices by Apple, Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.