510(k) K101127

PATIENT MONITOR, MODEL PM50 by Contec Medical System Co., Ltd. — Product Code MWI

K101127 is an FDA 510(k) premarket notification submitted by Contec Medical System Co., Ltd. for the device "PATIENT MONITOR, MODEL PM50". The FDA issued a decision of Substantially Equivalent on June 11, 2010. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Contec Medical System Co., Ltd. has at least 10 other 510(k) clearances on record.