Name: Predicase
Price: 199 USD

K-number	K203224
Device name	Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
Applicant	Edwards Lifesciences, LLC
Product code	QAQ
Device class	Class II
Decision date	Jul 30, 2021
Decision	Substantially Equivalent
Regulation	870.2210

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Source

View the full FDA submission: accessdata.fda.gov

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Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

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