510(k) K203687

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index by Edwards Lifesciences, LLC — Product Code DQK

K203687 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index". The FDA issued a decision of Substantially Equivalent on May 28, 2021. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Edwards Lifesciences, LLC has 157 other 510(k) clearances on record.