The following data is part of a premarket notification filed by Iradimed Corporation with the FDA for Mridium 3850 Mri Pump System.
| Device ID | K050301 |
| 510k Number | K050301 |
| Device Name: | MRIDIUM 3850 MRI PUMP SYSTEM |
| Classification | Pump, Infusion |
| Applicant | IRADIMED CORPORATION 7457 ALOMA AVENUE SUITE 201 Winter Park, FL 32792 |
| Contact | Francis X Casey |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-08 |
| Decision Date | 2005-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856038001055 | K050301 | 000 |
| 00856038001041 | K050301 | 000 |
| 10856038001024 | K050301 | 000 |
| 00856038001836 | K050301 | 000 |