FDA 510(k) Application Details - K203594

Device Classification Name	More FDA Info for this Device
510(K) Number	K203594
Device Name	EyeCTester
Applicant	Neuro-Eye Diagnostic Systems LLC 2020 Quenby St. Houston, TX 77005 US Other 510(k) Applications for this Company
Contact	Jade S. Schiffman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2020
Decision Date	09/07/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review