MEDI-TRACE QUIKSET DX DIAG. ELECT-

MEDI-TRACE QUIKSET DX DIAG. ELECT- is an FDA 510(k)-cleared medical device (K834445) 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 March 31, 1984. Regulation: 8.