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FDA 510(k) Applications Submitted by Varad Raghuwanshi
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230057
01/09/2023
Acumen Hypotension Prediction Index (HPI) Algorithm
Edwards Lifesciences LLC
K201446
06/01/2020
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
Edwards Lifesiences, LLC
K221833
06/23/2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Edwards Life Sciences LLC
K203687
12/17/2020
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
Edwards lifesciences, LLC
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