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Ge Medical Systems Information Technologies
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T-WAVE ALTERNANS (TWA) ALGORITHM OPTION is an FDA 510(k)-cleared medical device (K032513) manufactured by Ge Medical Systems Information Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2003. Regulation: 8.