FDA Product Code
FDA Product Code QRS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 868.2376
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250874 | Sunrise | Sunrise SA | 2025-08-29 | Traditional | PDF ↗ |
| K222262 | Sunrise | Sunrise SA | 2022-12-22 | Traditional | PDF ↗ |
| DEN210015 | Sunrise Sleep Disorder Diagnostic Aid | Sunrise | 2022-01-07 | Direct | — |
Product code QRS · Class II · Ear, Nose, Throat. Data: openFDA.