Diagnosis, treatment or monitoring of patients under medical surveillance, with the patient has physical or electrical contact, and/or to the patient to transmit or from the patient to obtain energy, and/or detection of these transmitted and obtained energy to the equipment. An electrocardiogram machine that provides an electrocardiogram pattern that can be removed for diagnostic purposes, including electrocardiogram vectorographs, load testing
Testing machines. Physiological medical equipment with electrocardiographic diagnostic functions consisting of electrocardiographic input boxes and computers, monitors, printers and the like. This provision does not apply to the electrocardiographic equipment is the electrocardiographic telemetry system, electrocardiographic monitor, 24-hour ambulatory electrocardiographic monitoring system
I hope that my answer can give you generation to help
Added: you look at the certification catalog
ca.gov.cn/cnca/zwxx/ggxx/images/20070706/2204. pdf
This is the first time that I have seen this product in the market. pdf