510(k) K162144 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
iHealth Wireless Blood Pressure Monitor
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Feb 1, 2017 |
| Received | Aug 1, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K162144
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.