K-number	K050301
Device name	MRIDIUM 3850 MRI PUMP SYSTEM
Applicant	Iradimed Corporation
Product code	FRN
Device class	Class II
Decision date	Mar 24, 2005
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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MRIDIUM 3850 MRI PUMP SYSTEM

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