FDA 510(k) Application Details - K171241

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K171241
Device Name	Oximeter
Applicant	Hunan Accurate Bio-Medical Technology Co., Ltd. M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Changsha 410208 CN Other 510(k) Applications for this Company
Contact	Zhou Le 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	04/27/2017
Decision Date	03/27/2018
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