510(k) K221113

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code MWI

K221113 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor". The FDA issued a decision of Substantially Equivalent on Dec 2, 2022. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has 158 other 510(k) clearances on record.