Cleared Traditional

Vios Monitoring System

K150992 · Vios Medical, Inc. · Cardiovascular
Dec 2015
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K150992 is an FDA 510(k) clearance for the Vios Monitoring System, 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 December 16, 2015, 245 days after receiving the submission on April 15, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K150992 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2015
Decision Date December 16, 2015
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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