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National Custom Ent., Inc.
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MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 is an FDA 510(k)-cleared medical device (K012263) manufactured by National Custom Ent., 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 October 9, 2001. Regulation: 8.