FDA 510(k) Application Details - K242116

Device Classification Name	More FDA Info for this Device
510(K) Number	K242116
Device Name	EyeBOX EBX-4.1
Applicant	Oculogica, Inc. 1477 S. Knowles Ave. #110F New Richmond, WI 54017 US Other 510(k) Applications for this Company
Contact	Rosina Samadani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2024
Decision Date	04/04/2025
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