Acumen Assisted Fluid Management (AFM) Software Feature

Acumen Assisted Fluid Management (AFM) Software Feature is an FDA 510(k)-cleared medical device (DEN190029) manufactured by Edwards Lifesciences. 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 12, 2020. Regulation: 8.