510(k) K212529 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Hypotension Decision Assist Model HDA-OR2
| Applicant | Directed Systems, Ltd., Cambridge, GB |
| Decision | Substantially Equivalent, Nov 23, 2021 |
| Received | Aug 11, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212529
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.