HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module is an FDA 510(k)-cleared medical device (K201446) manufactured by Edwards Lifesiences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 30, 2020. Regulation: 8.