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510(k) K090087

MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM by Iradimed Corporation — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2009
Date Received
January 13, 2009
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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