510(k) K131763

TRUSCOPE SERIES PATIENT MONITOR by Guangdong Biolight Meditech Co., Ltd. — Product Code MHX

K131763 is an FDA 510(k) premarket notification submitted by Guangdong Biolight Meditech Co., Ltd. for the device "TRUSCOPE SERIES PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on July 15, 2013. 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. Guangdong Biolight Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.