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FDA 510(k) Applications Submitted by Michelle Ducca
FDA 510(k) Number
Submission Date
Device Name
Applicant
K231038
04/12/2023
Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC
K221704
06/13/2022
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
Edwards Lifesciences, LLC
K222117
07/18/2022
Swang-Ganz IQ pulmonary artery catheter
Edwards Lifesiences, LLC
K223127
10/03/2022
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Edwards Lifeciences, LLC
K203490
11/27/2020
FORE-SIGHT ELITE Absolute Tissue Oximeter
Edwards Lifesciences, LLC
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