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FDA 510(k) Application Details - K202388
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K202388
Device Name
System, X-Ray, Stationary
Applicant
VMI Tecnologias LTDA
Rua Prefeito Elizeu Alves Da Silva, 400 Dist. Ind. Genesco
Aparecido De Oliveira, Lagoa Santa 33400000 BR
Other 510(k) Applications for this Company
Contact
Siele Santos
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2020
Decision Date
12/01/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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