510(k) K170876

Passport Series Patient Monitors(Passport 12m, Passport 17m) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code MHX

K170876 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "Passport Series Patient Monitors(Passport 12m, Passport 17m)". The FDA issued a decision of Substantially Equivalent on Aug 23, 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.