FDA 510(k) Application Details - K190772

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K190772
Device Name	System, X-Ray, Angiographic
Applicant	OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-Shi 192-8507 JP Other 510(k) Applications for this Company
Contact	Toshiyuki Nakajima 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	03/26/2019
Decision Date	10/10/2019
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