510(k) K254048 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
| Applicant | Shenzhen Urion Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 14, 2026 |
| Received | Dec 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254048
No recall in the FDA data names this 510(k).
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