FDA 510(k) Application Details - K203537

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K203537
Device Name	System, X-Ray, Stationary
Applicant	SEDECAL SA C/ Pelaya, 9-13 Pol. Ind. Rio de Janeiro Algete 28110 ES Other 510(k) Applications for this Company
Contact	Ma Luisa Gomez de Aguero 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	12/03/2020
Decision Date	02/01/2021
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