NEXXIS OR

Display, Cathode-ray Tube, Medical

BARCO NV

The following data is part of a premarket notification filed by Barco Nv with the FDA for Nexxis Or.

Pre-market Notification Details

Device IDK122167
510k NumberK122167
Device Name:NEXXIS OR
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-23
Decision Date2013-04-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415334002081 K122167 000
05415334002074 K122167 000
05415334002067 K122167 000
05415334002036 K122167 000
05415334001787 K122167 000
05415334001770 K122167 000
05415334001701 K122167 000
05415334001664 K122167 000
05415334001657 K122167 000

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