FDA 510(k) Application Details - K170837

Device Classification Name	More FDA Info for this Device
510(K) Number	K170837
Device Name	Nio Color 3MP (MDNC-3421)
Applicant	Barco NV President Kennedypark 35 Kortrijk 8500 BE Other 510(k) Applications for this Company
Contact	Helena Soenen 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	03/21/2017
Decision Date	04/05/2017
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