MDPC-8127

Whole Slide Imaging System

Barco NV

The following data is part of a premarket notification filed by Barco Nv with the FDA for Mdpc-8127.

Pre-market Notification Details

Device IDK203364
510k NumberK203364
Device Name:MDPC-8127
ClassificationWhole Slide Imaging System
Applicant Barco NV President Kennedypark 35 Kortrijk,  BE 8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
Barco NV President Kennedypark 35 Kortrijk,  BE 8500
Product CodePSY  
CFR Regulation Number864.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-16
Decision Date2021-04-15

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