LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30

LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 is an FDA 510(k)-cleared medical device (K100217) manufactured by Mediana Co., 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 June 7, 2010. Regulation: 8.