MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE

MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE is an FDA 510(k)-cleared medical device (K963038) 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 November 14, 1996. Regulation: 8.