Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

Cogent™ Hemodynamic Monitoring System; Cogent™ HMS is an FDA 510(k)-cleared medical device (K232048) manufactured by Icu Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2023. Regulation: 8.