FDA 510(k) Application Details - K213984

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K213984
Device Name	Oximeter
Applicant	ShenZhen ZhengKang Technology Co., Ltd. 2&3/F, Building A, No. 3 FuXing Yi Lane, HeHua Community, PingHu Street, LongGang District ShenZhen 518100 CN Other 510(k) Applications for this Company
Contact	Huayong Yang 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	12/20/2021
Decision Date	12/16/2022
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