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3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Over-The-Counter Device To Assess Risk Of Sleep Apnea

Device class

Class II (moderate risk)

Regulation

21 CFR 868.2378

Medical specialty

Anesthesiology

FDA definition

An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.

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