510(k) K214045 ยท FRN Pump, Infusion
FreedomEdge Syringe Infusion System
| Applicant | Repro-Medical System, Inc., Dba Koru Medical Systems, New York NY, US |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Dec 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214045
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.