CARDIOCASSETTE II, AMBULATORY ECG SYSTEM

CARDIOCASSETTE II, AMBULATORY ECG SYSTEM is an FDA 510(k)-cleared medical device (K790509) manufactured by Cambridge Instruments, 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 March 22, 1979. Regulation: 8.