EWC: ECG II CABLE LEADWIRE SYSTEM

EWC: ECG II CABLE LEADWIRE SYSTEM is an FDA 510(k)-cleared medical device (K984263) manufactured by Ewc. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 1, 1999. Regulation: 8.