FDA 510(k) Application Details - K131601

Device Classification Name	More FDA Info for this Device
510(K) Number	K131601
Device Name	DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
Applicant	QUBYX LIMITED 80, RUE MARECHAL JOFFRE NICE 06000 FR Other 510(k) Applications for this Company
Contact	ALICE KOTYLARENKO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2013
Decision Date	07/07/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review