510(k) K191106

C50 and C80 Multi-parameter Patient Monitor by Shenzhen Comen Medical Instruments Co.,Ltd — Product Code MHX

K191106 is an FDA 510(k) premarket notification submitted by Shenzhen Comen Medical Instruments Co.,Ltd for the device "C50 and C80 Multi-parameter Patient Monitor". The FDA issued a decision of Substantially Equivalent on December 13, 2019. 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. Shenzhen Comen Medical Instruments Co.,Ltd has at least 4 other 510(k) clearances on record.