FDA 510(k) Application Details - K211632

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K211632
Device Name	Oximeter
Applicant	Shenzhen Narig Bio-Medical Technology Co., Ltd. 1106 Room, East Tower, Digital Culture Industry Base No.10128 Shennan Road, Nanshan District Shenzhen 518052 CN Other 510(k) Applications for this Company
Contact	Fei Han 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	05/27/2021
Decision Date	01/14/2022
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