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Critikon Company, LLC
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DINAMAP PRO 1000 MONITOR, MODEL 1000 is an FDA 510(k)-cleared medical device (K002248) manufactured by Critikon Company, 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 20, 2000. Regulation: 8.