510(k) K171901

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code MHX

K171901 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)". The FDA issued a decision of Substantially Equivalent on Nov 15, 2017. 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 158 other 510(k) clearances on record.