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