Compliance Consultants has created many 510(k) applications for hardware / software used for remote tele-medicine devices where ambulatory monitoring is critical and seconds count. A software system communicates an enhanced ECG's telephone monitoring system. The patient at home or first responders use typically a single-lead ECG monitor to capture suspected arrhythmia and initiate a telephone call to transmit the digitally recorded segment to a central station where software presents the segment on a computer display for further analysis. The practitioner can then transmit the data to a cardiologist for diagnostic interpretation.


This planning tool allows the communication of data so necessary facilities can be waiting to save a life. Where time is critical, advanced information to can display the segment on a computer display for further analysis and initiate planning to receive patients for better treatment outcomes.


Tele medicine / Ambulatory Monitoring equipment captures biological data, (such as imaging data or single-lead ECG for suspected arrhythmia) and initiate communications to transmit the digitally recorded segment to a central station monitoring site. Advanced computer software can display the segment on a computer display for further analysis and action.


Remote medical monitoring lowers the cost of medical services. Regulation Number:21 CFR 870.2340. Product Code: DPS.