FDA 510(k) Application Details - K220101

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K220101
Device Name	Oximeter
Applicant	Beijing Choice Electronic Technology Co., Ltd. 2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building No. 9 Shuangyuan Road Shijingshan Beijing 100041 CN Other 510(k) Applications for this Company
Contact	Haiying Zhao 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	01/12/2022
Decision Date	03/08/2023
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