510(k) DEN210015

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

January 7, 2022

Date Received

April 2, 2021

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Device For Sleep Apnea Testing Based On Mandibular Movement

Device Class

Class II

Regulation Number

868.2376

Review Panel

AN

Submission Type

A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.