Cleared Traditional

Vios Central Station Monitor Software, Vios Central Server Software

K173107 · Vios Medical, Inc. · Cardiovascular

Jul 2018

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K173107 is an FDA 510(k) clearance for the Vios Central Station Monitor Software, Vios Central Server Software, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Vios Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 26, 2018, 300 days after receiving the submission on September 29, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number	K173107 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	July 26, 2018
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF