510(k) K243291 · HGP Electrode, Circular (Spiral), Scalp And Applicator
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
| Applicant | Neoventa Medical AB, Mölndal, SE |
| Decision | Substantially Equivalent, Jan 17, 2025 |
| Received | Oct 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243291
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.