FDA Product Code
FDA Product Code SFH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.3755
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN240068 | ArteraAI Prostate | Artera, Inc. | 2025-07-31 | Direct | — |
Product code SFH · Class II · Pathology. Data: openFDA.