Device For Sleep Apnea Testing Based On Mandibular Movement
The Device for Sleep Apnea Testing Based on Mandibular Movement is a prescription device that aids in the evaluation of sleep apnea by analyzing sensor readings of mandibular (jaw) movement during sleep, identifying patterns associated with sleep-disordered breathing in patients suspected of having obstructive sleep apnea. It is not intended as a substitute for full polysomnography and must not be used as an apnea monitor. Classified as FDA Class 2 under regulation 868.2376, it requires 510(k) clearance and is reviewed under Anesthesiology with an Ear, Nose, and Throat specialty designation. It is not an implant and not life-sustaining.
Basic Information
- Product Code
- QRS
- Device Class
- FDA class 2
- Regulation Number
- 868.2376
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.