Clearance Summary
MRidium 3860+ MRI infusion Pump/ Monitoring System received FDA 510(k) clearance under submission number K143369, sponsored by Iradimed Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-12-15.
- Submission: K143369
- Applicant / Sponsor: Iradimed Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2016-12-15
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.