510(k) K100046

M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 by Guangdong Biolight Meditech Co., Ltd. — Product Code MHX

K100046 is an FDA 510(k) premarket notification submitted by Guangdong Biolight Meditech Co., Ltd. for the device "M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000". The FDA issued a decision of Substantially Equivalent on April 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. Guangdong Biolight Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.