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Levitronix, LLC
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LEVITRONIX CENTRIMAG BACK-UP CONSOLE is an FDA 510(k)-cleared medical device (K051209) manufactured by Levitronix, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2005. Regulation: 8.