510(k) K143195

Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. — Product Code MHX

K143195 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. for the device "Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)". The FDA issued a decision of Substantially Equivalent on Dec 22, 2014. 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-Meidcal Electronics Co., Ltd. has 8 other 510(k) clearances on record.