659671c2-e419-4709-966e-d5eee8a6f491NewPublished12022-12-082022-11-30In Commercial Distribution04538612909092PrimaryGS1FUKUDA DENSHICC-82690671011FUKUDA DENSHI CO.,LTD.1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK15003000033586General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.falseActiveMHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)falsefalse