510(k) K193520 ยท HIF Insufflator, Laparoscopic
EVA 15 Insufflator
| Applicant | Palliare , Ltd., Galway, IE |
| Decision | Substantially Equivalent, Jul 23, 2020 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193520
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.