FDA 510(k) Application Details - K193033

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K193033
Device Name	Stimulator, Auditory, Evoked Response
Applicant	Grason Stadler 10395 West 70th Street Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Brent Nissly 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	10/31/2019
Decision Date	04/24/2020
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