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510(k) Data Aggregation
K Number
K241728Device Name
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
Manufacturer
Murata Vios, Inc.
Date Cleared
2025-01-23
(223 days)
Product Code
DXN, DPZ, DQA, DRG, DRT, DXJ, OUG
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Murata Vios, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously, and patient posture and activity. VMS allows for the input of non-invasive blood pressure and body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive Blood Pressure Tracking feature is based on Pulse Arrival Time (PAT), which is obtained utilizing ECG and PPG signals following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
The Vios Central Station Monitor (CSM) and Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.
Device Description
The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals.
The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station.
The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices.
The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW.
VMS Chest Sensor Adapter Models L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.
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K Number
K232354Device Name
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
Manufacturer
Murata Vios, Inc.
Date Cleared
2024-03-22
(228 days)
Product Code
DRT, DPZ, DQA, DRG, DSI, DXJ, MHX, OUG
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Murata Vios, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters.
VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions.
The Vos CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSMCS SW receives, stores, and displays patient physiological and waveform data and alams generated by Vios proprietary patient vitals monitoring software.
Device Description
The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use,
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