ECG MONITORING/DEFIBRILLATION ELECTRODE

ECG MONITORING/DEFIBRILLATION ELECTRODE is an FDA 510(k)-cleared medical device (K854433) manufactured by Andover Medical, 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 May 7, 1986. Regulation: 8.