510(k) K253228 · DXN System, Measurement, Blood-Pressure, Non-Invasive
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
| Applicant | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., Danyang, CN |
| Decision | Substantially Equivalent, Feb 23, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.