510(k) K250464 · QEB Ventilatory Electrical Impedance Tomograph
Enlight 2100 (TPL-E2103-0)
| Applicant | Timpel S.A., São Paulo, BR |
| Decision | Substantially Equivalent, Sep 10, 2025 |
| Received | Feb 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250464
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.