510(k) K254129 ยท MUD Oximeter, Tissue Saturation
Spectrum-2
| Applicant | Neko Health AB, Danderyd, SE |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Dec 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254129
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.