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Device For Sleep Apnea Testing Based On Mandibular Movement

Device For Sleep Apnea Testing Based On Mandibular Movement is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Device For Sleep Apnea Testing Based On Mandibular Movement
Ear, Nose, Throat Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QRS

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Class 2

21 CFR 868.2376

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Ear, Nose, Throat

Device Characteristics

No

No

No

Not Eligible

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.