FDA 510(k) Application Details - K151287

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K151287
Device Name	Oximeter
Applicant	GUANGDONG BIOLIGHT MEDITECH CO., LTD. INNOVATION FIRST ROAD TECHNOLOGY INNOVATION COAST ZHUHAI 519085 CN Other 510(k) Applications for this Company
Contact	Jin Liang 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	05/14/2015
Decision Date	01/06/2016
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