510(k) K131898

A SERIES AND Q SERIES PATIENT MONITORS by Guangdong Biolight Meditech Co., Ltd. — Product Code MWI

K131898 is an FDA 510(k) premarket notification submitted by Guangdong Biolight Meditech Co., Ltd. for the device "A SERIES AND Q SERIES PATIENT MONITORS". The FDA issued a decision of Substantially Equivalent on February 18, 2014. 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. Guangdong Biolight Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.