FDA 510(k) Application Details - K201177

Device Classification Name	Irradiator, Blood To Prevent Graft Versus Host Disease   More FDA Info for this Device
510(K) Number	K201177
Device Name	Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant	R3 X-Ray L.L.C 2730 E. Broadway BLVD STE 160 Tucson, AZ 85716 US Other 510(k) Applications for this Company
Contact	Robert Hase Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MOT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2020
Decision Date	08/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review