QRS — Device For Sleep Apnea Testing Based On Mandibular Movement Class II
Classification Details
- Product Code
- QRS
- Device Class
- Class II
- Regulation Number
- 868.2376
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.