FDA 510(k) Application Details - K133132

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K133132
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	NIDEK CO., LTD. 755 N. MATHILDA AVENUE SUITE 100 SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	DARLENE CROCKETT-BILLIG 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	09/30/2013
Decision Date	06/11/2014
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