The following data is part of a premarket notification filed by Vmi Tecnologias Ltda with the FDA for Aquila 320 D / Aquila 320 S.
Device ID | K201340 |
510k Number | K201340 |
Device Name: | AQUILA 320 D / AQUILA 320 S |
Classification | System, X-ray, Mobile |
Applicant | VMI Tecnologias LTDA Rua Prefeito Elizeu Alves Da Silva, 400 Dist. Ind. Genesco Aparecido De Oliveira, Lagoa Santa, BR 33400000 |
Contact | Siele Santos |
Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-20 |
Decision Date | 2020-06-19 |