NIO COLOR 3MP LED

System, Image Processing, Radiological

BARCO NV

The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Color 3mp Led.

Pre-market Notification Details

Device IDK131295
510k NumberK131295
Device Name:NIO COLOR 3MP LED
ClassificationSystem, Image Processing, Radiological
Applicant BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-06
Decision Date2013-05-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415334001121 K131295 000
05415334001114 K131295 000
05415334001107 K131295 000

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