510(k) K250854

Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) by Shenzhen Comen Medical Instruments Co.,Ltd — Product Code MHX

K250854 is an FDA 510(k) premarket notification submitted by Shenzhen Comen Medical Instruments Co.,Ltd for the device "Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)". The FDA issued a decision of Substantially Equivalent on December 17, 2025. 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.