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Device device for sleep apnea testing based on mandibular movement
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.
Product CodeQRS
Regulation Number 868.2376
Device Class 2


Premarket Reviews
ManufacturerDecision
SUNRISE
  GRANTED 1
SUNRISE SA
  SUBSTANTIALLY EQUIVALENT 1

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