ECOM™ Cardiac Output Monitoring System

ECOM™ Cardiac Output Monitoring System is an FDA 510(k)-cleared medical device (K172196) manufactured by Ecom Medical, Inc.. 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 18, 2017. Regulation: 8.