510(k) K222280 · QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Bigfoot Unity® Diabetes Management System
| Applicant | Bigfoot Biomedical, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Mar 1, 2023 |
| Received | Jul 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222280
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.