Device typeWearable multiple vital physiological parameter monitoring system: A portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database.
FDA categoryMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Device ID00843997011549
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information