510(k) K260062 ยท QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
MODI System
| Applicant | DreaMed Diabetes, Ltd., Petah Tikva, IL |
| Decision | Substantially Equivalent, Sep 8, 2026 |
| Received | Jan 8, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260062
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.