Visaris Avanse

System, X-ray, Stationary

VISARIS D.o.o. Belgrade

The following data is part of a premarket notification filed by Visaris D.o.o. Belgrade with the FDA for Visaris Avanse.

Pre-market Notification Details

Device IDK150725
510k NumberK150725
Device Name:Visaris Avanse
ClassificationSystem, X-ray, Stationary
Applicant VISARIS D.o.o. Belgrade Batajnicki Drum 10 Deo 1b Zemun,  RS 11080
ContactMilan Ratkovic
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-20
Decision Date2015-06-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08606102809033 K150725 000

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