SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200

SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 is an FDA 510(k)-cleared medical device (K091513) manufactured by Edan 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 July 23, 2009. Regulation: 8.