FDA Product Code
FDA Product Code SGX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6512
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250004 | QIKCAP System | Hai Solutions | 2025-12-23 | Direct | — |
Product code SGX · Class II · General Hospital. Data: openFDA.