510(k) K253170

uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code MHX

K253170 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors". The FDA issued a decision of Substantially Equivalent on April 16, 2026. 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 Mindray Bio-Medical Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.