510(k) K243115 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83
| Applicant | Shenzhen Urion Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 21, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243115
No recall in the FDA data names this 510(k).
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