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Reynolds Medical , Ltd.
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CARDIODIRECT, MODELS 12M, 12I, 12S is an FDA 510(k)-cleared medical device (K024283) manufactured by Reynolds Medical , 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 July 31, 2003. Regulation: 8.