FDA 510(k) Application Details - K250096

Device Classification Name	More FDA Info for this Device
510(K) Number	K250096
Device Name	Felix NeuroAI System
Applicant	Fasikl Incorporated 8500 Normandale Lake Blvd, Suite 400 Bloomington, MN 55437 US Other 510(k) Applications for this Company
Contact	Zhen Zhang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2025
Decision Date	07/01/2025
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