K-number	K173612
Device name	Optima XR646 HD
Applicant	Ge Hualun Medical Systems Co. , Ltd.
Product code	KPR
Device class	Class II
Decision date	Dec 11, 2017
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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Optima XR646 HD

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