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