510(k) K214040 ยท HAW Neurological Stereotaxic Instrument
ClearPoint Array System (version 1.1)
| Applicant | ClearPoint Neuro, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 12, 2022 |
| Received | Dec 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214040
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.