K262472
- 510(k) number
- K262472
- Device name
- Stelo Glucose Biosensor System
- Applicant
- Dexcom, Inc. CA · US
- Product code
- SBH — Integrated Continuous Glucose Monitor For Non-Intens
- Decision date
- 2026-08-11
- Date received
- 2026-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K262472.pdf
Official FDA record: K262472
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.