510(k) K230474 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
EVA5 Insufflator
| Applicant | Palliare , Ltd., Galway, IE |
| Decision | Substantially Equivalent, Mar 24, 2023 |
| Received | Feb 22, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230474
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.