FDA Product Code
FDA Product Code QWS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6886
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242732 | Tristel OPH | Tristel Solutions , Ltd. | 2025-05-09 | Traditional | PDF ↗ |
| DEN220041 | Tristel Duo ULT | Tristel Solutions Limited | 2023-06-02 | Direct | — |
Product code QWS · Class II · General Hospital. Data: openFDA.