510(k) K240860 ยท SDJ Adjunctive Cardiac Amyloidosis Status Indicator
EchoGo Amyloidosis (1.0)
| Applicant | Ultromics Limited, Oxford, GB |
| Decision | Substantially Equivalent, Nov 15, 2024 |
| Received | Mar 28, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240860
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.