FDA Product Code
FDA Product Code SBA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1357
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated | 2024-09-16 | Traditional | PDF ↗ |
| DEN230052 | Eversense AP CGM System | Senseonics, Incorporated | 2024-04-29 | Direct | — |
Product code SBA · Class II · Clinical Chemistry. Data: openFDA.