FDA 510(k) Application Details - K243636

Device Classification Name	More FDA Info for this Device
510(K) Number	K243636
Device Name	Neuralytix iD3 System (NTX-9001)
Applicant	Neuralytix LLC 138 S Park Square Ste 203 Fruita, CO 81521 US Other 510(k) Applications for this Company
Contact	Christopher Wybo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2024
Decision Date	06/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review