KOSTEC MEDICAL GRADE LDC MONITORS

KOSTEC MEDICAL GRADE LDC MONITORS is an FDA 510(k)-cleared medical device (K123944) manufactured by Kostec Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 4, 2013. Regulation: 8.