K-number	K201325
Device name	Optomed Smartscope M5 with Optomed Smartscope FA
Applicant	Optomed Oyj
Product code	HKI
Device class	Class II
Decision date	Nov 20, 2020
Decision	Substantially Equivalent
Regulation	886.1120

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Source

View the full FDA submission: accessdata.fda.gov

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Optomed Smartscope M5 with Optomed Smartscope FA

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