K-number	K132186
Device name	OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
Applicant	Optomed OY
Product code	HKI
Device class	Class II
Decision date	Dec 18, 2013
Decision	Substantially Equivalent
Regulation	886.1120

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View the full FDA submission: accessdata.fda.gov

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OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2

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