
Cardiodynamics International Corp.
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BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 is an FDA 510(k)-cleared medical device (K001081) 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 June 29, 2000. Regulation: 8.