MDMC-12133

Display, Diagnostic Radiology

BARCO N.V.

The following data is part of a premarket notification filed by Barco N.v. with the FDA for Mdmc-12133.

Pre-market Notification Details

Device IDK141428
510k NumberK141428
Device Name:MDMC-12133
ClassificationDisplay, Diagnostic Radiology
Applicant BARCO N.V. 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
BARCO N.V. 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-30
Decision Date2014-06-27
Summary:summary

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