FDA 510(k) Application Details - K232888

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K232888
Device Name	Stimulator, Nerve
Applicant	Suzhou Haishen Medical Device Associates Co., Ltd 3F, 4F (Room 401, 402), 5F, Building 10, No. 168, Majian Rd Suzhou High-tech Zone Suzhou 215000 CN Other 510(k) Applications for this Company
Contact	Leyi Dai Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2023
Decision Date	12/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review