510(k) K211206 ยท FRN Pump, Infusion
FreedomEdge(R) Syringe Infusion System
| Applicant | Repro-Medical System, Inc., Dba Koru Medical Systems, New York NY, US |
| Decision | Substantially Equivalent, Nov 9, 2021 |
| Received | Apr 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211206
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.