K-number	K162285
Device name	EBM iDO Viewer 1.2.1
Applicant	Ebm Technologies Incorporated
Product code	LLZ
Device class	Class II
Decision date	Jan 27, 2017
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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EBM iDO Viewer 1.2.1

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