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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K211143
Device Name Pulse Oximeter
Applicant
Shenzhen brav electronic technologies co., Ltd
R4-5/F, Block 11, Tongfuyu Industrial District, Lezhujiao,
Huangmabu, Baoan
Shenzhen,  CN 518060
Applicant Contact Kai Wang
Correspondent
Shenzhen brav electronic technologies co., Ltd
R4-5/F, Block 11, Tongfuyu Industrial District, Lezhujiao,
Huangmabu, Baoan
Shenzhen,  CN 518060
Correspondent Contact Yolanda Lan
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/16/2021
Decision Date 07/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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