FDA 510(k)

MRidium 3860+ MRI infusion Pump/ Monitoring System

K-Number: K143369 · 2016-12-15

Decision Date2016-12-15

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MRidium 3860+ MRI infusion Pump/ Monitoring System is a medical device manufactured by Iradimed Corporation. It received FDA 510(k) clearance on 2016-12-15 under approval number K143369. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRidium 3860+ MRI infusion Pump/ Monitoring System?

MRidium 3860+ MRI infusion Pump/ Monitoring System is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Iradimed Corporation. The 510(k) number is K143369.

When was MRidium 3860+ MRI infusion Pump/ Monitoring System approved by the FDA?

MRidium 3860+ MRI infusion Pump/ Monitoring System received FDA 510(k) clearance on 2016-12-15, under approval number K143369.

What company makes MRidium 3860+ MRI infusion Pump/ Monitoring System?

MRidium 3860+ MRI infusion Pump/ Monitoring System is manufactured by Iradimed Corporation.

What is the FDA product code for MRidium 3860+ MRI infusion Pump/ Monitoring System?

The FDA product code for MRidium 3860+ MRI infusion Pump/ Monitoring System is FRN.

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Other Devices by Iradimed Corporation

K1722003880 MRI Patient Monitoring System K1829003880 MRI Patient Monitoring System K1809033880 MRI Patient Monitoring System K242752MRidium 3870 MRI Infusion Pump System (3870)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.