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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 a medical device manufactured by Apple, Inc.. It received FDA 510(k) clearance on 2024-09-13 under approval 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. It is manufactured by Apple, Inc.. The 510(k) number is K240929.

When was Sleep Apnea Notification Feature (SANF) approved by the FDA?

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

What company makes Sleep Apnea Notification Feature (SANF)?

Sleep Apnea Notification Feature (SANF) is manufactured by Apple, Inc..

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

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

Related Clinical Trials

NCT07613944 Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders NOT_YET_RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING NCT05977296 Obstructive Sleep Apnea (OSA), Oral Frailty, Dysphagia, Continuous Positive Airway Pressure (CPAP) COMPLETED NCT07600333 CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children NOT_YET_RECRUITING NCT07595185 Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Other Devices by Apple, Inc.

DEN180044ECG App DEN180042Irregular Rhythm Notification Feature K201525ECG App K212516IRNF App K213971Atrial Fibrillation History Feature K231173Irregular Rhythm Notification Feature (IRNF)

View all 12 devices →

Related Devices (Code: QZW)

DEN230041Sleep Apnea FeatureSamsung 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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