510(k) K231897 ยท HAW Neurological Stereotaxic Instrument
NeuroAlign software
| Applicant | Medivis, Inc., New York NY, US |
| Decision | Substantially Equivalent, Oct 21, 2025 |
| Received | Jun 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231897
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.