FDA 510(k) Application Details - K221471

Device Classification Name	Stimulator, Photic, Evoked Response   More FDA Info for this Device
510(K) Number	K221471
Device Name	Stimulator, Photic, Evoked Response
Applicant	Diagnosys LLC 55 Technology Drive, Suite 100 Lowell, MA 01851 US Other 510(k) Applications for this Company
Contact	Jeffrey Farmer Other 510(k) Applications for this Contact
Regulation Number	882.1890   More FDA Info for this Regulation Number
Classification Product Code	GWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2022
Decision Date	11/22/2022
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