
Medicotest A/S
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BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA is an FDA 510(k)-cleared medical device (K020382) manufactured by Medicotest 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 June 27, 2002. Regulation: 8.