FDA 510(k) Application Details - K171877

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K171877
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	Chongqing Kanghua Ruiming S&T Co., Ltd. No.5, Road1, Tongjiaxi Industrial Park, Beibei Chongqing 400070 CN Other 510(k) Applications for this Company
Contact	Xi You 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	06/23/2017
Decision Date	12/21/2017
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