MEDI-TRACE DISPOSABLE DOMES/MONITORING

MEDI-TRACE DISPOSABLE DOMES/MONITORING is an FDA 510(k)-cleared medical device (K800706) 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 April 15, 1980. Regulation: 8.