FDA 510(k) Application Details - K230303

Device Classification Name	More FDA Info for this Device
510(K) Number	K230303
Device Name	AccuFFRangio Plus
Applicant	ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District Hangzhou 310051 CN Other 510(k) Applications for this Company
Contact	Jianping Xiang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2023
Decision Date	03/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review