CORONIS 2MP AND MDCG 2121 - CB

System, Image Processing, Radiological

BARCOVIEW

The following data is part of a premarket notification filed by Barcoview with the FDA for Coronis 2mp And Mdcg 2121 - Cb.

Pre-market Notification Details

Device IDK061926
510k NumberK061926
Device Name:CORONIS 2MP AND MDCG 2121 - CB
ClassificationSystem, Image Processing, Radiological
Applicant BARCOVIEW 35 PRESIDENT KENNEDYPARK Kortrijk,  BE B-8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
BARCOVIEW 35 PRESIDENT KENNEDYPARK Kortrijk,  BE B-8500
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-07
Decision Date2006-08-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.