510(k) K213536 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
DEKA ACE Pump System
| Applicant | Deka Research and Development, Manchester NH, US |
| Decision | Substantially Equivalent, Jul 25, 2023 |
| Received | Nov 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213536
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.