Name: Predicase
Price: 199 USD

K-number	K201446
Device name	HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
Applicant	Edwards Lifesiences, LLC
Product code	DQK
Device class	Class II
Decision date	Oct 1, 2020
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

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