ALLON 2001 VERSION 5

ALLON 2001 VERSION 5 is an FDA 510(k)-cleared medical device (K024128) manufactured by Mtre Advanced Technology , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2003. Regulation: 8.