FDA 510(k) Application Details - K201408

Device Classification Name	More FDA Info for this Device
510(K) Number	K201408
Device Name	Demetra Analytics Toolkit
Applicant	Barco NV President Kennedypark 35 Kortrijk 8500 BE Other 510(k) Applications for this Company
Contact	Julie Vandecandelaere Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2020
Decision Date	02/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review