DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540

DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 is an FDA 510(k)-cleared medical device (K950475) 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 November 13, 1995. Regulation: 8.