The following data is part of a premarket notification filed by Iradimed Corporation with the FDA for Mridium 3860+ Mri Infusion Pump/ Monitoring System.
| Device ID | K143369 |
| 510k Number | K143369 |
| Device Name: | MRidium 3860+ MRI Infusion Pump/ Monitoring System |
| Classification | Pump, Infusion |
| Applicant | IRADIMED CORPORATION 1025 WILLA SPRINGS DRIVE Winter Springs, FL 32708 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey IRADIMED CORPORATION 1025 WILLA SPRINGS DRIVE Winter Springs, FL 32708 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-25 |
| Decision Date | 2016-12-15 |
| Summary: | summary |