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 | K090087 |
| 510k Number | K090087 |
| Device Name: | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM |
| Classification | Pump, Infusion |
| Applicant | IRADIMED CORPORATION 7457 ALOMA AVE., 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 | 2009-01-13 |
| Decision Date | 2009-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856038001683 | K090087 | 000 |
| 00856038001089 | K090087 | 000 |
| 00856038001096 | K090087 | 000 |
| 00856038001102 | K090087 | 000 |
| 00856038001119 | K090087 | 000 |
| 00856038001126 | K090087 | 000 |
| 00856038001133 | K090087 | 000 |
| 00856038001140 | K090087 | 000 |
| 00856038001157 | K090087 | 000 |
| 00856038001164 | K090087 | 000 |
| 00856038001072 | K090087 | 000 |