FDA 510(k) Application Details - K212310

Device Classification Name	More FDA Info for this Device
510(K) Number	K212310
Device Name	EyeBOX (Model EBX-4)
Applicant	Oculogica, Inc. 33 Irving Place New York, NY 10003 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	07/23/2021
Decision Date	12/22/2021
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