K-number	K131892
Device name	EV1000 CLINICAL PLATFORM
Applicant	Edwards Lifesciences, LLC
Product code	DXG
Device class	Class II
Decision date	May 22, 2014
Decision	Substantially Equivalent
Regulation	870.1435

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Source

View the full FDA submission: accessdata.fda.gov

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EV1000 CLINICAL PLATFORM

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