MEDI-TRACE 200, MEDI-TRACE 200-30

MEDI-TRACE 200, MEDI-TRACE 200-30 is an FDA 510(k)-cleared medical device (K960968) manufactured by Graphic Controls Corp.. 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 27, 1996. Regulation: 8.