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Device For Sleep Apnea Testing Based On Mandibular Movement

FDA product code QRS · 2 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 868.2376
Review panel
AN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-12-22 – 2025-08-29

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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