510(k) K200434 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
V20, V20a, AVSM3 SNF
| Applicant | Mediana Co., Ltd., Wonju-Si, KR |
| Decision | Substantially Equivalent, Oct 9, 2020 |
| Received | Feb 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2021 | Mediana Co., Ltd. AVSM3 SNF, Vital Signs Monitor
The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for a Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.