K-number	K100709
Device name	EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
Applicant	Edwards Lifesciences, LLC
Product code	DXG
Device class	Class II
Decision date	Dec 7, 2010
Decision	Substantially Equivalent
Regulation	870.1435

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EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

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