FDA Product Code DXN: System, Measurement, Blood-pressure, Non-invasive

Under FDA product code DXN, non-invasive blood pressure measurement systems are cleared for clinical and ambulatory use.

These devices use oscillometric or auscultatory methods to measure systolic and diastolic blood pressure without arterial puncture. They range from bedside monitors to ambulatory devices that record pressure over 24-hour periods for hypertension diagnosis and management.

DXN devices are Class II medical devices, regulated under 21 CFR 870.1130 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Andon Health Co, Ltd., Health & Life Co., Ltd. and Omron Healthcare, Inc..