FDA 510(k) Application Details - K150821

Device Classification Name	More FDA Info for this Device
510(K) Number	K150821
Device Name	MDNG-3220 (Nio 3MP LED)
Applicant	Barco President Kennedypark 35 Kortrijk 8500 BE Other 510(k) Applications for this Company
Contact	Lieven De Wandel 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	03/27/2015
Decision Date	04/10/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review