Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor

About This 510(k) Submission

K221113 is an FDA 510(k) clearance for the Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 2, 2022, 231 days after receiving the submission on April 15, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.