510(k) K213799

N Series Patient Monitors by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code MHX

K213799 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "N Series Patient Monitors". The FDA issued a decision of Substantially Equivalent on Jul 12, 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 Mindray Bio-Medical Electronics Co., Ltd. has 158 other 510(k) clearances on record.