FDA 510(k) Application Details - K150722

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K150722
Device Name	Ophthalmoscope, Ac-Powered
Applicant	BIOPTIGEN, INC. 633 DAVIS DRIVE, SUITE 480 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	Tammy B Carrea 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	03/20/2015
Decision Date	12/02/2015
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