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Ebit Sanita, S.P.A.
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ORG@NIZER, MODEL VERSION 3.0 is an FDA 510(k)-cleared medical device (K030363) manufactured by Ebit Sanita, S.P.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 26, 2003. Regulation: 8.