SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE

SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE is an FDA 510(k)-cleared medical device (K080106) manufactured by Leonhard Lang GmbH. 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 31, 2008. Regulation: 8.