K-number	K192160
Device name	EVO Platform
Applicant	Quanta System Spa
Product code	GEX
Device class	Class II
Decision date	Sep 6, 2019
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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EVO Platform

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