FDA 510(k) Application Details - K153080

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K153080
Device Name	Ophthalmoscope, Ac-Powered
Applicant	OPTOVUE, INC. 2800 BAYVIEW DRIVE FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	EDWARD SINCLAIR 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	10/23/2015
Decision Date	02/11/2016
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