DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is an FDA 510(k)-cleared medical device (K163054) manufactured by Osprey 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 March 7, 2017. Regulation: 8.