The following data is part of a premarket notification filed by Iradimed Corporation with the FDA for 3880 Mri Patient Monitoring System.
| Device ID | K180903 |
| 510k Number | K180903 |
| Device Name: | 3880 MRI Patient Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Iradimed Corporation 1025 Willa Springs Dr. Winter Springs, FL 32708 |
| Contact | Francis X. Casey |
| Correspondent | Francis X. Casey Iradimed Corporation 1025 Willa Springs Dr. Winter Springs, FL 32708 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-06 |
| Decision Date | 2019-03-29 |