
Cardiosoft, L.P.
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CARDIOSOFT PC ECG, USB VERSION is an FDA 510(k)-cleared medical device (K052295) manufactured by Cardiosoft, L.P.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2006. Regulation: 8.