FDA 510(k) Application Details - K101505

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K101505
Device Name	Ophthalmoscope, Ac-Powered
Applicant	OPTOVUE, INC. 45531 NORTHPORT LOOP W. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	JOHN TALARICO Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	HLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2010
Decision Date	09/15/2010
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