Masimo Radius VSM Patient-Worn Vital Signs Monitor - HSA Registration DE0508734
Access comprehensive regulatory information for Masimo Radius VSM Patient-Worn Vital Signs Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508734 and owned by Masimo Corporation. The device was registered on December 07, 2023.
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Radius VSM is intended for use as both wearable multi-parameter patient monitor and accessory to a multi-parameter patient monitor intended for physiological patient monitoring in hospitals, healthcare facilities and home. Radius VSM is indicated for monitoring hemodynamic (including ECG, arrhythmia detection, NiBP, SpO2, Pulse Rate, PVi, heart rate and temperature), and respiratory (e.g. impedance, acoustic, pleth-based respiration rate) physiological parameters along with orientation and activity of adults. Radius VSM is indicated for the non-invasive continuous monitoring of SpO2 and PR for well or poorly perfused adults during no motion and motion conditions, monitoring of body temperature, orientation and activity of patients including those susceptible to pressure ulcers, and PVi as a measure of relative variability of photoplethysmograph (pleth) during no motion conditions. PVi may be used as a dynamic indicator of fluid responsiveness in select mechanically ventilated patients.