K-number	K150398
Device name	EUM 100Pro
Applicant	Ob Tools, Ltd.
Product code	HGM
Device class	Class II
Decision date	Aug 6, 2015
Decision	Substantially Equivalent
Regulation	884.2740

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Source

View the full FDA submission: accessdata.fda.gov

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EUM 100Pro

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