FDA 510(k) Application Details - K163564

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K163564
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	NIDEK CO., LTD. 34-14 Maehama, Hiroishicho Gamagori 443-0038 JP Other 510(k) Applications for this Company
Contact	Yoneji Mizuno 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	12/19/2016
Decision Date	05/19/2017
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