510(k) K151520 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Oscar 2
| Applicant | Suntech Medical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Feb 19, 2016 |
| Received | Jun 5, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K151520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2020 | Suntech Medical, Inc. Oscar 2, Model 250 System Terminated |
DXN | None listed |
| Dec 11, 2019 | Suntech Medical, Inc. Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99- Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.