
Cardiodynamics International Corp.
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BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 is an FDA 510(k)-cleared medical device (K070156) 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 25, 2007. Regulation: 8.