DEN230052
- 510(k) number
- DEN230052
- Device name
- Eversense AP CGM System
- Applicant
- Senseonics, Incorporated MD · US
- Product code
- SBA — Integrated Continuous Glucose Monitoring System With
- Decision date
- 2024-04-29
- Date received
- 2023-08-09
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Clinical Chemistry
Official FDA record: DEN230052
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.