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Device over-the-counter device to assess risk of sleep apnea
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.
Product CodeQZW
Regulation Number 868.2378
Device Class 2


Premarket Reviews
ManufacturerDecision
SAMSUNG ELECTRONICS CO., LTD
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