GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)

GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) is an FDA 510(k)-cleared medical device (K921929) manufactured by General Devices. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 1992. Regulation: 8.