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510(k) K254048

Device
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
Applicant
Shenzhen Urion Technology Co., Ltd.
510(k) number
K254048
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-14
Date received
2025-12-17
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

Applicant Contact#

Contact
Fraser Liu
Address
Floor 4-6th Of Bldg. D, Jiale Science & Technology Industrial Zone, #3, Chuang Wei Rd., Heshuikou Community Shenzhen CN 518106 518106

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.2026-08-26
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K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)Honsun (Nantong) Co., Ltd.2026-04-28
K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.2026-04-21
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