QRS · Device For Sleep Apnea Testing Based On Mandibular Movement
Ear, Nose, Throat · 21 CFR 868.2376 · Class 2
Overview
| Product Code | QRS |
|---|---|
| Device Name | Device For Sleep Apnea Testing Based On Mandibular Movement |
| Regulation | 21 CFR 868.2376 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250874 | Sunrise | Sunrise SA | Aug 29, 2025 | SESE |
| K222262 | Sunrise | Sunrise SA | Dec 22, 2022 | SESE |
| DEN210015 | Sunrise Sleep Disorder Diagnostic Aid | Sunrise | Jan 7, 2022 | DENG |
Top Applicants
- Sunrise SA — 2 clearances
- Sunrise — 1 clearance
