K-number	K150767
Device name	EDOSE
Applicant	Guangzhou Raydose Software Technology., LLC
Product code	IYE
Device class	Class II
Decision date	Aug 17, 2015
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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EDOSE

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