Cleared Special

NIVR58-T kit

K161880 · Barco N.V. · Cardiovascular
Mar 2017
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K161880 is an FDA 510(k) clearance for the NIVR58-T kit, 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 March 14, 2017, 249 days after receiving the submission on July 8, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K161880 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2016
Decision Date March 14, 2017
Days to Decision 249 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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