Name: Predicase
Price: 199 USD

K-number	K160552
Device name	EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
Applicant	Edwards Lifesciences, LLC
Product code	DXN
Device class	Class II
Decision date	Jun 1, 2016
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform

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