ELVI 810 CLOTSCANNER

ELVI 810 CLOTSCANNER is an FDA 510(k)-cleared medical device (K791587) manufactured by Volu Sol Medical Industries. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 1979. Regulation: 8.