FDA 510(k) Application Details - K181771

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K181771
Device Name	Nystagmograph
Applicant	RightEye, LLC 7979 Old Georgetown Rd., Suite 801 Bethesda, MD 20814 US Other 510(k) Applications for this Company
Contact	Adam Gross Other 510(k) Applications for this Contact
Regulation Number	882.1460   More FDA Info for this Regulation Number
Classification Product Code	GWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2018
Decision Date	09/28/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review