K-DEFIB/PACE CARBON ELECTRODE

K-DEFIB/PACE CARBON ELECTRODE is an FDA 510(k)-cleared medical device (K926175) manufactured by Katecho, 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 April 14, 1993. Regulation: 8.