TRACE RITE SOLID GEL ECG ELECTRODES

TRACE RITE SOLID GEL ECG ELECTRODES is an FDA 510(k)-cleared medical device (K964213) manufactured by Bio-Detek, 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 24, 1996. Regulation: 8.