FDA 510(k) Application Details - K162991

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K162991
Device Name	System, X-Ray, Angiographic
Applicant	Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena 07745 DE Other 510(k) Applications for this Company
Contact	Peter Schrutka-Rechtenstamm Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2016
Decision Date	07/24/2017
Decision	SESD - SUBST EQUIV - WITH DRUG
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review