FDA 510(k) Application Details - K003442

Device Classification Name	Photostimulator, Ac-Powered   More FDA Info for this Device
510(K) Number	K003442
Device Name	Photostimulator, Ac-Powered
Applicant	ELECTRO-DIAGNOSTIC IMAGING, INC. 2081 LONGDEN CIRCLE LOS ALTOS, CA 94024 US Other 510(k) Applications for this Company
Contact	SHEILA W PICKERING Other 510(k) Applications for this Contact
Regulation Number	886.1630   More FDA Info for this Regulation Number
Classification Product Code	HLX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2000
Decision Date	05/04/2001
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