FDA 510(k) Application Details - K201340

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K201340
Device Name	System, X-Ray, Mobile
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	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2020
Decision Date	06/19/2020
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