510(k) K260242 ยท BTY Calculator, Predicted Values, Pulmonary Function
CPETWise Platform
| Applicant | Medibyt , Ltd., Yakum, IL |
| Decision | Substantially Equivalent, Aug 20, 2026 |
| Received | Jan 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260242
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.