FDA 510(k) Application Details - K242954

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K242954
Device Name	Stimulator, Auditory, Evoked Response
Applicant	Vivosonic Inc 222-5535 Eglinton Avenue West Toronto M9C 5K5 CA Other 510(k) Applications for this Company
Contact	Trevor Rocheleau Other 510(k) Applications for this Contact
Regulation Number	882.1900   More FDA Info for this Regulation Number
Classification Product Code	GWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review