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Computerized Screening, Inc.
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CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K is an FDA 510(k)-cleared medical device (K101198) manufactured by Computerized Screening, 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 August 3, 2010. Regulation: 8.