PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)

PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) is an FDA 510(k)-cleared medical device (K963578) manufactured by Intl. Products, 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 June 29, 1997. Regulation: 8.