ACCU-TRODE (DISP. ECG ELECTRODE)

ACCU-TRODE (DISP. ECG ELECTRODE) is an FDA 510(k)-cleared medical device (K771392) manufactured by Warner/Chilcott. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 15, 1977. Regulation: 8.