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MyCardio, LLC
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CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE is an FDA 510(k)-cleared medical device (K092003) manufactured by MyCardio, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2009. Regulation: 8.