FDA 510(k) Application Details - K250094

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K250094
Device Name	Electrode, Cortical
Applicant	Neuralynx, Inc. 105 Commercial Drive Bozeman, MT 59715 US Other 510(k) Applications for this Company
Contact	Kelly Moeykens Other 510(k) Applications for this Contact
Regulation Number	882.1310   More FDA Info for this Regulation Number
Classification Product Code	GYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2025
Decision Date	04/14/2025
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