FDA 510(k) Application Details - K231075

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K231075
Device Name	System, X-Ray, Angiographic
Applicant	Carl Zeiss Meditec Inc 5300 Central Parkway Dublin, CA 94568 US Other 510(k) Applications for this Company
Contact	Chaitali Gawde 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	04/14/2023
Decision Date	06/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review