CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH

CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K013367) manufactured by Reynolds Medical , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2001. Regulation: 8.