510(k) DEN230052
- Device
- Eversense AP CGM System
- Applicant
- Senseonics, Incorporated
- 510(k) number
- DEN230052
- Product code
- SBA
- Decision
- Unknown (DENG)
- Decision date
- 2024-04-29
- Date received
- 2023-08-09
- Regulation
- 862.1357
- Classification name
- Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mukul Jain
- Address
- 20451 Seneca Meadows Pkwy. Germantown MD US 20876 20876
FDA Registration Numbers#
- 3004530184
- 2183744
- 3006371704
- 3009862700
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SBA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated | 2024-09-16 |