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M Series Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR). Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. Note: M7000 does not have functions of Invasive Blood Pressure and Carbon Dioxide.

The proposed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000, are modification devices to the existed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000 as cleared in K100046 at 04/08/2010. The proposed devices and the existed devices share same intended use, design principle and technical specifications. The main modification of the proposed devices is adding a SpO2 module, which was designed and manufactured by Masimo Corporation and previously cleared by FDA in K053269 at 12/21/2005. It is an independent module installed within the patient monitor, without any other modifications, and shall be used with the specified accessories, which are listed in following table.