Cleared Traditional

SIVR56-T KIT

K133994 · Barco N.V. · Cardiovascular
Dec 2014
Decision
340d
Days
Class 2
Risk

About This 510(k) Submission

K133994 is an FDA 510(k) clearance for the SIVR56-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 December 1, 2014, 340 days after receiving the submission on December 26, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K133994 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2013
Decision Date December 01, 2014
Days to Decision 340 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

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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