K-number	K153429
Device name	SmartView 3D Option
Applicant	Ge Hangwei Medical System Co., Ltd.
Product code	JAK
Device class	Class II
Decision date	Mar 9, 2016
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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SmartView 3D Option

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