ECG-6 SERIES ELECTROCARDIOGRAPH

ECG-6 SERIES ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K112135) manufactured by Advanced Instrumentations, 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 August 4, 2011. Regulation: 8.