MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES

MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES is an FDA 510(k)-cleared medical device (K863369) manufactured by Tdk 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 January 5, 1987. Regulation: 8.