Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software— 510(k) K232354

Name: FDA 510(k) clearance K232354
Creator: U.S. Food and Drug Administration
Published: 2024-03-22

Substantially Equivalent

Murata Vios, Inc.

FDA 510(k) clearance K232354 for Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software, Substantially Equivalent on 2024-03-22. Applicant: Murata Vios, Inc.. Device class: 2.

Clearance details

Applicant: Murata Vios, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2023-08-07
Decision date: 2024-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodbury, MN, US

Download summary PDF View on FDA.gov ↗

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K253388 — Sleepiz One+ (Model 2.5)2026-01-28
K251364 — Sleepiz One+ (2.5)2025-07-29
K234003 — The Circadia C200 System2024-05-30

More clearances from Murata Vios, Inc.

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K241728 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 20502025-01-23

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.