FDA 510(k) Application Details - K022304

Device Classification Name	Stimulator, Photic, Evoked Response   More FDA Info for this Device
510(K) Number	K022304
Device Name	Stimulator, Photic, Evoked Response
Applicant	OBJECTIVISION PTY LTD. 185 JORDAN RD. TROY, NY 12180 US Other 510(k) Applications for this Company
Contact	FRED HENRY 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	07/16/2002
Decision Date	11/14/2003
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