FDA 510(k) Application Details - K101763

Device Classification Name	Stimulator, Photic, Evoked Response   More FDA Info for this Device
510(K) Number	K101763
Device Name	Stimulator, Photic, Evoked Response
Applicant	DIOPSYS INC. 44 COUNTRYWOOD DRIVE PINE BROOK, NJ 07058 US Other 510(k) Applications for this Company
Contact	RICHARD HETTENBACH 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	06/23/2010
Decision Date	05/09/2011
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