FDA 510(k) Application Details - K220072

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K220072
Device Name	Neurological Stereotaxic Instrument
Applicant	Sinovation (Beijing) Medical Technology Co., Ltd Rm 401, Bld 12-1, No.26 Yongwang West Road, Z-park Daxing Beijing 102600 CN Other 510(k) Applications for this Company
Contact	Manman Xu Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2022
Decision Date	06/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review