FDA 510(k) Application Details - K130656

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K130656
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	OPTOVUE, INC. 2800 Bayview Dr FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	WILLIAM "BILL" JACKSON Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2013
Decision Date	07/03/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review