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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 K253228
Device Name YUWELL® Electronic Blood Pressure Monitor (YE650AR)
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
#1 Baisheng Rd. Development Zone
Danyang,  CN 212300
Applicant Contact Zhang Fang (Fawn)
Correspondent
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
#1 Baisheng Rd. Development Zone
Danyang,  CN 212300
Correspondent Contact Zhang Fang (Fawn)
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/29/2025
Decision Date 02/23/2026
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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