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Cardio Medical Products, Inc.
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CARDIO MED MODEL A102, H104, O101, P103, AND Z100 is an FDA 510(k)-cleared medical device (K103159) manufactured by Cardio Medical Products, Inc.. 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 10, 2011. Regulation: 8.