Name: Predicase
Price: 199 USD

K-number	K203131
Device name	EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
Applicant	Edwards Lifesciences, LLC
Product code	DXN
Device class	Class II
Decision date	Jan 22, 2021
Decision	Substantially Equivalent
Regulation	870.1130

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform

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