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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
Predetermined Change
Control Plan Authorized		 No
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