FDA 510(k)

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

K-Number: K232354 · 2024-03-22

Decision Date2024-03-22

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software is a medical device manufactured by Murata Vios, Inc.. It received FDA 510(k) clearance on 2024-03-22 under approval number K232354. The device is classified under product code DRT. 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?

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Murata Vios, Inc.. The 510(k) number is K232354.

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

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software received FDA 510(k) clearance on 2024-03-22, under approval number K232354.

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

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

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

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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.

K241728Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050

Related Devices (Code: DRT)

K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorIvy Biomedical Systems, Inc. K170828Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K172586Vios Monitoring System Model 2050Vios Medical, Inc. K181165Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems K202138Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc.

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.