FDA 510(k) Application Details - K203364

Device Classification Name	More FDA Info for this Device
510(K) Number	K203364
Device Name	MDPC-8127
Applicant	Barco NV 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	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2020
Decision Date	04/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review