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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 K222926
Device Name Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
Applicant
Shenzhen Yuezhongxing Technology Co., Ltd.
#2, Zhenye Rd., Liulian Community, Pingshan Ave.,
Pingshan District
Shenzhen,  CN 518015
Applicant Contact Yuchao Chen
Correspondent
Shenzhen Yuezhongxing Technology Co., Ltd.
#2, Zhenye Rd., Liulian Community, Pingshan Ave.,
Pingshan District
Shenzhen,  CN 518015
Correspondent Contact Yuchao Chen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/26/2022
Decision Date 05/05/2023
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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