Name: Predicase
Price: 199 USD

K-number	K140312
Device name	EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
Applicant	Edwards Lifesciences, LLC
Product code	DXN
Device class	Class II
Decision date	Jun 13, 2014
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 TM FINGER CUFF OR CLEARSIGHT TM SYSTEM

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