HemoSphere Advanced Monitor, HemoSphere ClearSight Module

HemoSphere Advanced Monitor, HemoSphere ClearSight Module is an FDA 510(k)-cleared medical device (K221833) manufactured by Edwards Lifesciences, 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 November 6, 2022. Regulation: 8.