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GE Healthcare
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GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) is an FDA 510(k)-cleared medical device (K062580) manufactured by GE Healthcare. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2007. Regulation: 8.