510(k) K253647 ยท CBK Ventilator, Continuous, Facility Use
Evita (V800); Evita (V600)
| Applicant | Draegerwerk AG & CO Kgaa, Luebeck, DE |
| Decision | Substantially Equivalent, May 7, 2026 |
| Received | Nov 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253647
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.