
Cardiodynamics International Corp.
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BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG is an FDA 510(k)-cleared medical device (K051228) 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 9, 2005. Regulation: 8.