UNIEXPERT 2 PLUS

System, X-ray, Stationary

Adani

The following data is part of a premarket notification filed by Adani with the FDA for Uniexpert 2 Plus.

Pre-market Notification Details

Device IDK200944
510k NumberK200944
Device Name:UNIEXPERT 2 PLUS
ClassificationSystem, X-ray, Stationary
Applicant Adani 7 Selitsky Str. Minsk,  BY 220075
ContactVladimir Linev
CorrespondentVladimir Linev
Adani 7 Selitsky Str. Minsk,  BY 220075
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-08
Decision Date2020-05-26
Summary:summary

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