Cleared Special

Nexxis OR

K173381 · Barco N.V. · Cardiovascular
Feb 2018
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K173381 is an FDA 510(k) clearance for the Nexxis OR, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on February 22, 2018, 115 days after receiving the submission on October 30, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K173381 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2017
Decision Date February 22, 2018
Days to Decision 115 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXJ — Display, Cathode-ray Tube, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2450

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