BIOZ SYSTEM & BIOZ PORTABLE

BIOZ SYSTEM & BIOZ PORTABLE is an FDA 510(k)-cleared medical device (K972320) 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 September 10, 1997. Regulation: 8.