MDNG-3220 (Nio 3MP LED)

Display, Diagnostic Radiology

Barco

The following data is part of a premarket notification filed by Barco with the FDA for Mdng-3220 (nio 3mp Led).

Pre-market Notification Details

Device IDK150821
510k NumberK150821
Device Name:MDNG-3220 (Nio 3MP LED)
ClassificationDisplay, Diagnostic Radiology
Applicant Barco President Kennedypark 35 Kortrijk,  BE 8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
Barco President Kennedypark 35 Kortrijk,  BE 8500
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-27
Decision Date2015-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415334000360 K150821 000
05415334000353 K150821 000
05415334000346 K150821 000
05415334000339 K150821 000

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