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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 K241578
Device Name Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
Applicant
Shenzhen Bsx Technology Electronics Co., Ltd.
Rm101&2/F~4/F, Bldg. #13, Ailian Industrial Park,
Wulian Community, Longgang Distric
Shenzhen,  CN 518116
Applicant Contact XiYu Lu
Correspondent
Shenzhen Bsx Technology Electronics Co., Ltd.
Rm101&2/F~4/F, Bldg. #13, Ailian Industrial Park,
Wulian Community, Longgang Distric
Shenzhen,  CN 518116
Correspondent Contact XiYu Lu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/03/2024
Decision Date 02/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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