510(k) K100217

LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 by Mediana Co., Ltd. — Product Code MHX

K100217 is an FDA 510(k) premarket notification submitted by Mediana Co., Ltd. for the device "LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30". The FDA issued a decision of Substantially Equivalent on June 8, 2010. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Mediana Co., Ltd. has at least 9 other 510(k) clearances on record.