COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION

COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION is an FDA 510(k)-cleared medical device (K871490) manufactured by Ge Medical Systems Information Technologies. 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 6, 1987. Regulation: 8.