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510(k) K050301

MRIDIUM 3850 MRI PUMP SYSTEM by Iradimed Corporation — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2005
Date Received
February 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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