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FDA 510(k)

Sleep Apnea Notification Feature (SANF)

K-Number: K240929 · 2024-09-13

ApplicantApple, Inc.
Decision Date2024-09-13
Product CodeQZW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sleep Apnea Notification Feature (SANF) is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240929. The device is classified under product code QZW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sleep Apnea Notification Feature (SANF)?

Sleep Apnea Notification Feature (SANF) is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Apple, Inc.. The 510(k) number is K240929.

When did Sleep Apnea Notification Feature (SANF) receive FDA 510(k) clearance?

Sleep Apnea Notification Feature (SANF) received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240929.

Who is the listed applicant for Sleep Apnea Notification Feature (SANF)?

The FDA 510(k) record lists Apple, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sleep Apnea Notification Feature (SANF)?

The FDA product code for Sleep Apnea Notification Feature (SANF) is QZW.

Other records listing Apple, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253582Medical Imaging Calibration Feature (MICF)K250507Hypertension Notification Feature (HTNF)K250143Digital Prism Correction Feature (DPCF)K242058Digital Prism Correction Feature (DPCF)K231173Irregular Rhythm Notification Feature (IRNF)K213971Atrial Fibrillation History Feature

View all 9 devices →

Related Devices (Code: QZW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261011Sleep Apnea Feature (v2.0)Samsung Electronics Co., Ltd.

Official Source

View on FDA Database →

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

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