CFM-800 COLOR FLOW MAPPING SYSTEM

CFM-800 COLOR FLOW MAPPING SYSTEM is an FDA 510(k)-cleared medical device (K924079) manufactured by Diasonics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 1993. Regulation: 8.