FDA 510(k) Application Details - K191314

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K191314
Device Name	Tonometer, Manual
Applicant	Chongqing Sunkingdom Medical Instrument Co., Ltd 1012, Block A of China Resource Center No.55 of XieJiaWan JiuLongPo Chongqing 400050 CN Other 510(k) Applications for this Company
Contact	Shulin Guo Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2019
Decision Date	12/19/2019
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