510(k) K254240 ยท QOK Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
Echo-2
| Applicant | Neko Health AB, Danderyd, SE |
| Decision | Substantially Equivalent, Sep 22, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254240
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.