FDA 510(k) Application Details - K232581

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K232581
Device Name	Electrode, Needle
Applicant	Suzhou Haishen Medical Device Associates Co., Ltd 3F, 4F (Room 401, 402), 5F, Building 10, No. 168 Majian Road, Suzhou High-tech Zone Suzhou CN Other 510(k) Applications for this Company
Contact	Leyi Dai Other 510(k) Applications for this Contact
Regulation Number	882.1350   More FDA Info for this Regulation Number
Classification Product Code	GXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2023
Decision Date	12/04/2023
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