FDA 510(k) Application Details - K141428

Device Classification Name	More FDA Info for this Device
510(K) Number	K141428
Device Name	MDMC-12133
Applicant	BARCO N.V. 35 PRESIDENT KENNEDYPARK 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	05/30/2014
Decision Date	06/27/2014
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