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