510(k) K190955 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Hypotension Decision Assist
| Applicant | Directed Systems, Ltd., Cambridge, GB |
| Decision | Substantially Equivalent, Nov 27, 2019 |
| Received | Apr 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190955
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.