510(k) K011971 ยท HAW Neurological Stereotaxic Instrument
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
| Applicant | Image-Guided Neurologics, Inc., Melbourne FL, US |
| Decision | Substantially Equivalent, Aug 3, 2001 |
| Received | Jun 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011971
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.