QRS — Device For Sleep Apnea Testing Based On Mandibular Movement Class II
FDA product code QRS covers "Device For Sleep Apnea Testing Based On Mandibular Movement", a Class II medical device regulated under 21 CFR 868.2376. Submissions are reviewed by the Ear, Nose, Throat panel. At least 3 recent 510(k) clearances have been granted under this product code.
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.