510(k) K170497 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
V10
| Applicant | Mediana Co., Ltd., Wonju-Si, KR |
| Decision | Substantially Equivalent, Dec 15, 2017 |
| Received | Feb 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2020 | Mediana Co., Ltd. DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.