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Device For Sleep Apnea Testing Based On Mandibular Movement

Page Type
Product Code
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.
Physical State
The device includes a cloud-based software that analyzes data from the sensor placed on the patient’s mandible. By analyzing patient’s mandibular movements, the device detects obstructive respiratory disturbances and provides notifications about the severity of obstructive sleep apnea.
Technical Method
The principle of operation is based on analyzing the mandibular movement signals recorded by the device.
Target Area
Mandible.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2376
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRS is linked to regulation 21CFR868.2376, which does not seem to exist yet. It may be pending at the moment.

Device For Sleep Apnea Testing Based On Mandibular Movement

Page Type
Product Code
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.
Physical State
The device includes a cloud-based software that analyzes data from the sensor placed on the patient’s mandible. By analyzing patient’s mandibular movements, the device detects obstructive respiratory disturbances and provides notifications about the severity of obstructive sleep apnea.
Technical Method
The principle of operation is based on analyzing the mandibular movement signals recorded by the device.
Target Area
Mandible.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2376
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRS is linked to regulation 21CFR868.2376, which does not seem to exist yet. It may be pending at the moment.