FDA 510(k) Application Details - K173123

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K173123
Device Name	Oximeter
Applicant	Shenzhen IMDK Medical Technology Co., Ltd. C Zone, 10F, Building 16, Yuanshan Industrial B Area Gongming Street Guangming District, Shenzhen CN Other 510(k) Applications for this Company
Contact	Xia Yuan 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	09/29/2017
Decision Date	08/13/2018
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