FDA 510(k) Application Details - K202391

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K202391
Device Name	System, X-Ray, Angiographic
Applicant	Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 US Other 510(k) Applications for this Company
Contact	Kathy A. Racosky 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	08/21/2020
Decision Date	01/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review