K-number	K090087
Device name	MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
Applicant	Iradimed Corporation
Product code	FRN
Device class	Class II
Decision date	Apr 7, 2009
Decision	Substantially Equivalent
Regulation	880.5725

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View the full FDA submission: accessdata.fda.gov

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MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM

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