FDA 510(k) Application Details - K243982

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K243982
Device Name	Stimulator, Electrical, Evoked Response
Applicant	Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI 53562 US Other 510(k) Applications for this Company
Contact	Judy Samson Other 510(k) Applications for this Contact
Regulation Number	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2024
Decision Date	01/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review