Demetra Analytics Toolkit

Light Based Imaging

Barco NV

The following data is part of a premarket notification filed by Barco Nv with the FDA for Demetra Analytics Toolkit.

Pre-market Notification Details

Device IDK201408
510k NumberK201408
Device Name:Demetra Analytics Toolkit
ClassificationLight Based Imaging
Applicant Barco NV President Kennedypark 35 Kortrijk,  BE 8500
ContactJulie Vandecandelaere
CorrespondentJulie Vandecandelaere
Barco NV President Kennedypark 35 Kortrijk,  BE 8500
Product CodePSN  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-28
Decision Date2021-02-18

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