Device typeWearable multiple vital physiological parameter monitor: A portable assembly of electrically-powered devices intended to be worn by an ambulatory patient in a healthcare setting for intermittent assessment or continuous monitoring of several vital physiologic parameters [e.g., electrocardiogram (ECG), respiration rate, haemoglobin oxygen saturation (SpO2)] while allowing freedom of movement (e.g., in step-down care areas). It includes processing hardware to be used with dedicated software (that may be pre-installed); the sensors, probes, and/or electrodes are not included. It typically incorporates a monitoring screen and may allow communication with a stationary device (e.g., off-the shelf computer).
FDA categoryMonitor, Bed Patient, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), System, Network And Communication, Physiological Monitors, Transmitters And Receivers, Physiological Signal, Radiofrequency
Device ID00850064210262
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information