510(k) K260935 ยท SBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Stelo Glucose Biosensor System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 12, 2026 |
| Received | Mar 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260935
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.