CYGNUS 12 LEAD ECG MODULE

CYGNUS 12 LEAD ECG MODULE is an FDA 510(k)-cleared medical device (K072950) manufactured by Cygnus, LLC. 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 21, 2008. Regulation: 8.