510(k) K163334 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
LiDCOunity v2 Hemodynamic Monitor
| Applicant | Lidco, Ltd., London, GB |
| Decision | Substantially Equivalent, Jun 5, 2017 |
| Received | Nov 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2020 | Lidco Ltd CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set). Terminated |
DXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.