510(k) K254225 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
| Applicant | Shenzhen HanHan Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 1, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254225
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.