K-number	K163703
Device name	VIVIX-S 1417N
Applicant	Vieworks Co., Ltd.
Product code	MQB
Device class	Class II
Decision date	Feb 8, 2017
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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VIVIX-S 1417N

Everything you need for a 510(k) submission. Nothing you don't.