Cleared Special

Nexxis OR, Nexxis

K170537 · Barco N.V. · Cardiovascular
Apr 2017
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K170537 is an FDA 510(k) clearance for the Nexxis OR, Nexxis, 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 April 21, 2017, 57 days after receiving the submission on February 23, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K170537 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2017
Decision Date April 21, 2017
Days to Decision 57 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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