510(k) K173454

Multi-parameter Patient Monitor, models C30 by Shenzhen Comen Medical Instruments Co.,Ltd — Product Code MHX

K173454 is an FDA 510(k) premarket notification submitted by Shenzhen Comen Medical Instruments Co.,Ltd for the device "Multi-parameter Patient Monitor, models C30". The FDA issued a decision of Substantially Equivalent on August 16, 2018. 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.