FDA 510(k) Application Details - K190497

Device Classification Name	More FDA Info for this Device
510(K) Number	K190497
Device Name	Ziehm 8000
Applicant	Ziehm Imaging GmbH Donaustrasse 31 Nuremberg 90451 DE Other 510(k) Applications for this Company
Contact	Steve Seeman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2019
Decision Date	11/20/2019
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