510(k) K222214 · FXY Hood, Surgical
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
| Applicant | Thi Total Healthcare Innovation GmbH, Feistritz Im Rosental, AT |
| Decision | Substantially Equivalent, Oct 17, 2023 |
| Received | Jul 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222214
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.