FDA 510(k) Application Details - K113451

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K113451
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	NIDEK TECHNOLOGIES SRL VIA DELL ARTIGIANATO, 6/A ALBIGNASEGO (PADOVA) 35020 IT Other 510(k) Applications for this Company
Contact	ENRICO BISSON Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2011
Decision Date	05/08/2012
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