510(k) K191422 ยท HAW Neurological Stereotaxic Instrument
Neural Navigator
| Applicant | Soterix Medical, Inc., New York NY, US |
| Decision | Substantially Equivalent, Apr 6, 2020 |
| Received | May 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191422
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.