Cleared Traditional

Vios Monitoring System? Model 2050

K172586 · Vios Medical, Inc. · Cardiovascular

Jun 2018

Decision

298d

Days

Class 2

Risk

About This 510(k) Submission

K172586 is an FDA 510(k) clearance for the Vios Monitoring System? Model 2050, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Vios Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 22, 2018, 298 days after receiving the submission on August 28, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K172586 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2017
Decision Date	June 22, 2018
Days to Decision	298 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF