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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 K260273
Device Name Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
Applicant
Shenzhen Urion Technology Co., Ltd.
Flr 4-6th Of Bldg. D, Jiale Science & Tech Indust Zone,#3
Chuang Wei Rd., Heshuikou Comm, Matian St.,Guangming New Dis
Shenzhen,  CN 518106
Applicant Contact Vivian Wang
Correspondent
Shenzhen Urion Technology Co., Ltd.
Flr 4-6th Of Bldg. D, Jiale Science & Tech Indust Zone,#3
Chuang Wei Rd., Heshuikou Comm, Matian St.,Guangming New Dis
Shenzhen,  CN 518106
Correspondent Contact Vivian Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/29/2026
Decision Date 03/26/2026
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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