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FDA 510(k)

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050

K-Number: K241728 · 2025-01-23

ApplicantMurata Vios, Inc.
Decision Date2025-01-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 is a medical device manufactured by Murata Vios, Inc.. It received FDA 510(k) clearance on 2025-01-23 under approval number K241728. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050?

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 is a medical device that received FDA 510(k) clearance on 2025-01-23. It is manufactured by Murata Vios, Inc.. The 510(k) number is K241728.

When was Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 approved by the FDA?

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 received FDA 510(k) clearance on 2025-01-23, under approval number K241728.

What company makes Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050?

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 is manufactured by Murata Vios, Inc..

What is the FDA product code for Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050?

The FDA product code for Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 is DXN.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07612683 Pulmonary Artery Catheters in Cardiac Surgery NOT_YET_RECRUITING NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026)

Other Devices by Murata Vios, Inc.

K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

Related Devices (Code: DXN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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