NEXAN SYSTEM, MODEL NX-300

NEXAN SYSTEM, MODEL NX-300 is an FDA 510(k)-cleared medical device (K003520) manufactured by Nexan, 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 December 12, 2000. Regulation: 8.