AQUILA 320 D / AQUILA 320 S

System, X-ray, Mobile

VMI Tecnologias LTDA

The following data is part of a premarket notification filed by Vmi Tecnologias Ltda with the FDA for Aquila 320 D / Aquila 320 S.

Pre-market Notification Details

Device IDK201340
510k NumberK201340
Device Name:AQUILA 320 D / AQUILA 320 S
ClassificationSystem, X-ray, Mobile
Applicant VMI Tecnologias LTDA Rua Prefeito Elizeu Alves Da Silva, 400 Dist. Ind. Genesco Aparecido De Oliveira, Lagoa Santa,  BR 33400000
ContactSiele Santos
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-06-19

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