510(k) K143369 ยท FRN Pump, Infusion
MRidium 3860+ MRI infusion Pump/ Monitoring System
| Applicant | Iradimed Corporation, Winter Springs FL, US |
| Decision | Substantially Equivalent, Dec 15, 2016 |
| Received | Nov 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2023 | Iradimed Corporation Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50, Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.