FDA Product Code
FDA Product Code SGN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4420
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250015 | Neurolyser XR (NXR100) | Fusmobile, Inc. | 2025-11-14 | Direct | — |
Product code SGN · Class II · Neurology. Data: openFDA.