510(k) K250151 ยท SDJ Adjunctive Cardiac Amyloidosis Status Indicator
Us2.ca
| Applicant | Eko.Ai Pte Ltd. D/B/A Us2.Ai, Singapore, SG |
| Decision | Substantially Equivalent, Jun 20, 2025 |
| Received | Jan 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250151
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.