Device For Sleep Apnea Testing Based On Mandibular Movement
QRS is the FDA product code for Device For Sleep Apnea Testing Based On Mandibular Movement, a class II device type, regulated under 21 CFR 868.2376. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QRS
- Device name
- Device For Sleep Apnea Testing Based On Mandibular Movement
- FDA 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.
- Regulation
- 21 CFR 868.2376
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code QRS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2025 | 1 |
Applicants with the most clearances
Product code QRS| Applicant | Clearances |
|---|---|
| Sunrise SA | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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