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 categoryElectrocardiograph, Ambulatory (Without Analysis), Monitor, Bed Patient, Monitor, Breathing Frequency, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), Thermometer, Electronic, Clinical, Transmitters And Receivers, Physiological Signal, Radiofrequency
Device ID00850064210026
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information