510(k) K223864 ยท HAW Neurological Stereotaxic Instrument
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Sep 9, 2023 |
| Received | Dec 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223864
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.