K-number	K123417
Device name	BRIVO MR355, OPTIMA MR360
Applicant	Ge Hangwei Medical Systems Co., Ltd.
Product code	LNH
Device class	Class II
Decision date	Jan 17, 2013
Decision	Substantially Equivalent
Regulation	892.1000

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View the full FDA submission: accessdata.fda.gov

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BRIVO MR355, OPTIMA MR360

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