GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300

GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 is an FDA 510(k)-cleared medical device (K940009) 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 April 13, 1995. Regulation: 8.