FDA 510(k) Application Details - K171392

Device Classification Name	Injector, Contrast Medium, Automatic   More FDA Info for this Device
510(K) Number	K171392
Device Name	Injector, Contrast Medium, Automatic
Applicant	ulrich GmbH & Co. KG Buchbrunnenweg 12 Ulm 89081 DE Other 510(k) Applications for this Company
Contact	Sven Erdmann Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	IZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2017
Decision Date	11/09/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review