510(k) K234070 ยท SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Stelo Glucose Biosensor System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 5, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234070
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.