MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR

MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR is an FDA 510(k)-cleared medical device (K011439) manufactured by Cardiodynamics International Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2001. Regulation: 8.