QRS

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Device For Sleep Apnea Testing Based On Mandibular Movement

Device class

Class II (moderate risk)

Regulation

21 CFR 868.2376

Medical specialty

Ear, Nose, Throat

FDA definition

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.

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