FDA 510(k) Application Details - K152091

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K152091
Device Name	Oximeter
Applicant	Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd NO. 8, Shengchang West Road,Danyang Economy Development Zone Jiang Su CN Other 510(k) Applications for this Company
Contact	Li Xu Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2015
Decision Date	08/18/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review