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Siemens Medical Solutions USA, Inc.
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INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II is an FDA 510(k)-cleared medical device (K012016) manufactured by Siemens Medical Solutions USA, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 2001. Regulation: 8.