FDA 510(k) Application Details - K183277

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K183277
Device Name	Oximeter
Applicant	Shenzhen Upnmed Equipment Co., Ltd. 4th Floor, Building #1 East, Huijuang Industrial Area Xitian Community, Gongming Town, Guangming District Shenzhen 518107 CN Other 510(k) Applications for this Company
Contact	Fu Jian 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	11/23/2018
Decision Date	05/15/2019
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