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Transoma Medical
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SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 is an FDA 510(k)-cleared medical device (K073147) manufactured by Transoma Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 2007. Regulation: 8.