510(k) K192972

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

K192972 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "Patient Monitor". The FDA issued a decision of Substantially Equivalent on May 7, 2020. 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.