510(k) K211619

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

K211619 is an FDA 510(k) premarket notification submitted by Shenzhen Comen Medical Instruments Co.,Ltd for the device "Multi-Parameter Patient Monitor". The FDA issued a decision of Substantially Equivalent on December 29, 2022. 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.