FDA 510(k) Application Details - K211143

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K211143
Device Name	Oximeter
Applicant	Shenzhen brav electronic technologies co., Ltd R4-5/F, Block 11, Tongfuyu Industrial District, Lezhujiao, Huangmabu, Baoan Shenzhen 518060 CN Other 510(k) Applications for this Company
Contact	Kai 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	04/16/2021
Decision Date	07/17/2023
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