K234070
- 510(k) number
- K234070
- Device name
- Stelo Glucose Biosensor System
- Applicant
- Dexcom, Inc. CA · US
- Product code
- SAF — Integrated Continuous Glucose Monitor For Non-Intens
- Decision date
- 2024-03-05
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K234070.pdf
Official FDA record: K234070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.