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Fluke Biomedical
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PROSIM 4, PROSIM 6, PROSIM 8 is an FDA 510(k)-cleared medical device (K110429) manufactured by Fluke Biomedical. 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 1, 2011. Regulation: 8.