FDA 510(k) Application Details - K242575

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K242575
Device Name	Neurological Stereotaxic Instrument
Applicant	Brain Navi Biotechnology Co., Ltd. No. 66-1, Shengyi 5th Rd., Zhubei City Hsinchu County 302041 TW Other 510(k) Applications for this Company
Contact	I-Ju Lu 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	08/29/2024
Decision Date	05/23/2025
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