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Pulsion Medical Systems AG
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PULSION PICCO-2, MODEL 8500 is an FDA 510(k)-cleared medical device (K072735) manufactured by Pulsion Medical Systems AG. 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 17, 2007. Regulation: 8.