FDA 510(k) Application Details - K160327

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K160327
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	VISIA IMAGING S.R.L VIA MARTIRI DELLA LIBERTA 95/E San Giovanni Valdarno 52027 IT Other 510(k) Applications for this Company
Contact	Silvia Fantechi Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	HJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2016
Decision Date	10/05/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review