FDA.report

510(k) K260273

Device
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.
510(k) number
K260273
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-26
Date received
2026-01-29
Regulation
870.1130
Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Vivian Wang
Address
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 518106

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DXN

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K260276Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S ProShenzhen AOJ Medical Technology Co., Ltd.2026-04-01
K254225Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)Shenzhen HanHan Technology Co., Ltd.2026-04-01
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K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-23
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K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-02-13
K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-01-12
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