FDA 510(k) Application Details - K202293

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K202293
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	M¬ Luisa G≤mez de Agⁿero 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	08/13/2020
Decision Date	10/07/2020
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