510(k) K254255 ยท DPS Electrocardiograph
S-Patch CardioAI
| Applicant | Wellysis Corp., Seoul, KR |
| Decision | Substantially Equivalent, Sep 25, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254255
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.