DISPOSABLE ECG MONITORING ELECTRODE

DISPOSABLE ECG MONITORING ELECTRODE is an FDA 510(k)-cleared medical device (K950473) manufactured by Nikomed U.S.A., 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 December 11, 1995. Regulation: 8.