Device typePhysiologic monitor-installed software: An application software program intended to be installed on a dedicated monitoring device (i.e., software in a medical device), to process and display real-time patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] to facilitate data viewing, management, and communication in a clinical setting. It may in addition notify clinicians of events, patients at risk, and/or manage workflows. It is not intended for intraoperative/intraprocedural monitoring and is neither dedicated to neonatal nor obstetrical monitoring.
FDA categoryAlarm, Blood-Pressure, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration), Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration), Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), Analyzer, Gas, Oxygen, Gaseous-Phase, Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration), Burst Suppression Detection Software For Electroencephalograph, Cerebral Oximeter, Computer, Blood-Pressure, Computer, Diagnostic, Pre-Programmed, Single-Function, Computer, Diagnostic, Programmable, Computer, Oxygen-Uptake, Continuous Measurement Thermometer, Detector And Alarm, Arrhythmia, Electrocardiograph, Full-Montage Standard Electroencephalograph, Index-Generating Electroencephalograph Software, Monitor, Airway Pressure (Includes Gauge And/Or Alarm), Monitor, Breathing Frequency, Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), Monitor, St Segment With Alarm, Non-Normalizing Quantitative Electroencephalograph Software, Oximeter, Oximeter, Ear, Oximeter, Tissue Saturation, Probe, Thermodilution, Reduced- Montage Standard Electroencephalograph, Spirometer, Monitoring (W/Wo Alarm), Stimulator, Auditory, Evoked Response, Stimulator, Nerve, Peripheral, Electric, System, Measurement, Blood-Pressure, Non-Invasive
Device ID00840682147811
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information