Device Classification Name |
System, X-Ray, Mobile
|
510(k) Number |
K201340 |
Device Name |
AQUILA 320 D / AQUILA 320 S |
Applicant |
VMI Tecnologias LTDA |
Rua Prefeito Elizeu Alves Da Silva, 400 Dist. Ind. Genesco |
Aparecido De Oliveira, Lagoa Santa,
BR
33400000
|
|
Applicant Contact |
Siele Santos |
Correspondent |
Kamm & Associates |
8870 Ravello Ct |
Naples,
FL
34114
|
|
Correspondent Contact |
Daniel Kamm |
Regulation Number | 892.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/20/2020 |
Decision Date | 06/19/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|