K-number	K180903
Device name	3880 MRI Patient Monitoring System
Applicant	Iradimed Corporation
Product code	MWI
Device class	Class II
Decision date	Mar 29, 2019
Decision	Substantially Equivalent
Regulation	870.2300

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Source

View the full FDA submission: accessdata.fda.gov

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3880 MRI Patient Monitoring System

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