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Card Guard Scientific Survival , Ltd.
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CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR is an FDA 510(k)-cleared medical device (K101639) manufactured by Card Guard Scientific Survival , 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 June 24, 2010. Regulation: 8.