CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS

CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS is an FDA 510(k)-cleared medical device (K950003) manufactured by Instromedix, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 1995. Regulation: 8.