Compliance Consultants has submitted 510(k) applications for these ambulatory blood pressure monitors that consist of a standard blood pressure cuff, an instrument (driven by computer firmware which records and collects blood pressure) that includes a software program that is resident in a Customer supplied P.C. that allows patient information and recorded blood pressure data to be displayed. This device is prescribed by a doctor for a patient {under observation} to wear for a period of time. The device collects and records blood pressure data information for display. This allows a facility to monitor, record and collect blood pressure data during a patient's normal daily routine to enhance the doctor's ability to render a diagnosis with actual blood pressure data concerning the patient's environment.


Portable, Personal, recording Blood Pressure Monitors Regulation Number: 21 CFR 870.1130, Product Code: DXN Blood Pressure Monitors / auscultatory reference methods ANSI/AAMI SP10 method BHS protocol and BTB 9.53-RLK 0691guidelines for guidelines of NIBP monitors. 21CFR870.1110, Product code DSK
21CFR870.1130. Product Code DXN