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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K260470
Device Name Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
Applicant
Shenzhen Brav Electronic Technologies Co., Ltd.
4-5/F, Block 11, Tongfuyu Industrial District,
Lezhujiao,Huangmabu, Baoan
Shenzhen,  CN 518060
Applicant Contact JinRan Bleu
Correspondent
Shenzhen Brav Electronic Technologies Co., Ltd.
4-5/F, Block 11, Tongfuyu Industrial District,
Lezhujiao,Huangmabu, Baoan
Shenzhen,  CN 518060
Correspondent Contact JinRan Bleu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/12/2026
Decision Date 10/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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