FDA Product Code MWI: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

FDA product code MWI covers physiological patient monitors without arrhythmia detection.

These devices continuously measure and display vital signs including ECG, heart rate, respiration, blood pressure, and oxygen saturation, but without automated arrhythmia analysis algorithms. They are used in general ward monitoring, step-down units, and procedural areas where continuous rhythm analysis is not required.

MWI devices are Class II medical devices, regulated under 21 CFR 870.2300 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Ge Medical Systems Information Technologies, Inc., Edan Instruments, Inc. and Shenzhen Mindray Bio-Medical Electronics Co., Ltd..