K-number	K143270
Device name	Optima XR646
Applicant	Ge Hualun Medical Systems Co. , Ltd.
Product code	KPR
Device class	Class II
Decision date	Feb 18, 2015
Decision	Substantially Equivalent
Regulation	892.1680

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View the full FDA submission: accessdata.fda.gov

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Optima XR646

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