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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 K254048
Device Name Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
Applicant
Shenzhen Urion Technology Co., Ltd.
Floor 4-6th Of Bldg. D, Jiale Science & Technology
Industrial Zone, #3, Chuang Wei Rd., Heshuikou Community
Shenzhen,  CN 518106
Applicant Contact Fraser Liu
Correspondent
Shenzhen Urion Technology Co., Ltd.
Floor 4-6th Of Bldg. D, Jiale Science & Technology
Industrial Zone, #3, Chuang Wei Rd., Heshuikou Community
Shenzhen,  CN 518106
Correspondent Contact Fraser Liu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/17/2025
Decision Date 05/14/2026
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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