K241335
- 510(k) number
- K241335
- Device name
- Eversense 365 Continuous Glucose Monitoring (CGM) System
- Applicant
- Senseonics, Incorporated MD · US
- Product code
- SBA — Integrated Continuous Glucose Monitoring System With
- Decision date
- 2024-09-16
- Date received
- 2024-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241335.pdf
Official FDA record: K241335
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.