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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K253089
Device Name NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
Applicant
Shenzhen Best Electronics Co., Ltd.
605 #59 Bldg., The Second Industrial Park
Tianliao Community, Yutang St., Guangming District
Shenzhen,  CN 518132
Applicant Contact Martin Wong
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park, #18 Shenzhou Rd.
Huangpu
Guangzhou,  CN 510663
Correspondent Contact Yijie You
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received09/23/2025
Decision Date 02/13/2026
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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