
National Custom Ent., Inc.
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MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC is an FDA 510(k)-cleared medical device (K012264) 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.