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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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