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510(k) K143369

MRidium 3860+ MRI infusion Pump/ Monitoring System by Iradimed Corporation — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2016
Date Received
November 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K050301 — MRIDIUM 3850 MRI PUMP SYSTEM (March 24, 2005)

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