AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S is an FDA 510(k)-cleared medical device (K041026) manufactured by Ambu, 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 June 27, 2004. Regulation: 8.