Cleared Traditional

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

K232354 · Murata Vios, Inc. · Cardiovascular

Mar 2024

Decision

228d

Days

Class 2

Risk

About This 510(k) Submission

K232354 is an FDA 510(k) clearance for the Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Murata Vios, Inc. (Woodbury, US). The FDA issued a Cleared decision on March 22, 2024, 228 days after receiving the submission on August 7, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K232354 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2023
Decision Date	March 22, 2024
Days to Decision	228 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF