ECG Information Management System is a medical device of several classes

The ECG information management system is a Class II medical device. Medical device class I refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices. Class II medical devices are medical devices whose safety and effectiveness should be controlled. Class III refers to medical devices that are implanted in the human body for the purpose of supporting and sustaining life. Potential danger to the human body, its safety, effectiveness must be strictly controlled medical devices. Cardiac information management system belongs to the second class of medical devices.