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Medcon , Ltd.
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HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 is an FDA 510(k)-cleared medical device (K061905) manufactured by Medcon , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2006. Regulation: 8.