DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 is an FDA 510(k)-cleared medical device (K990111) manufactured by Maersk Medical A/S. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 1999. Regulation: 8.