FDA 510(k) Application Details - K214097

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K214097
Device Name	System, X-Ray, Angiographic
Applicant	SurgVision GmbH Kistlerhof Strasse 70, Building 79 Munich 81379 DE Other 510(k) Applications for this Company
Contact	Daniela Mahan 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	12/28/2021
Decision Date	02/25/2022
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