FDA 510(k) Application Details - K120057

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K120057
Device Name	Ophthalmoscope, Ac-Powered
Applicant	BIOPTIGEN, INC. 104 T.W. ALEXANDER DRIVE P.O. BOX 13569 DURHAM, NC 27709 US Other 510(k) Applications for this Company
Contact	DAWN REILLY-O'DELL 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	01/09/2012
Decision Date	05/11/2012
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