FDA 510(k) Application Details - K212665

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K212665
Device Name	Oximeter
Applicant	Huizhou Xiaoou Technology Co., Ltd. 3rd Floor, No.113 (Building D), Xikeng Industrial Zone Zhongkai High-tech Zone Huizhou 516000 CN Other 510(k) Applications for this Company
Contact	Xia Wang 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	08/23/2021
Decision Date	06/22/2022
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