HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is an FDA 510(k)-cleared medical device (K211465) manufactured by Edwards Lfesciences. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2021. Regulation: 8.