510(k) DEN230041

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

February 6, 2024

Date Received

May 31, 2023

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

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

Device Class

Class II

Regulation Number

868.2378

Review Panel

AN

Submission Type

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.