FDA 510(k) Application Details - K213986

Device Classification Name	More FDA Info for this Device
510(K) Number	K213986
Device Name	CerebralGo Plus
Applicant	Yukun (Beijing) Technology Co., Ltd Room 313/315, Building 3, No.11 Chuangxin Road, Science Park Beijing 102200 CN Other 510(k) Applications for this Company
Contact	Wang Qi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2021
Decision Date	04/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review