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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
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