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Next Millennium Software Solutions, Inc.
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CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 is an FDA 510(k)-cleared medical device (K001091) manufactured by Next Millennium Software Solutions, 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 9, 2000. Regulation: 8.