510(k) K001642 ยท HAW Neurological Stereotaxic Instrument
INSIGHT IMAGE GUIDED SURGICAL SYSTEM
| Applicant | Surgical Insights, Inc., Evanston IL, US |
| Decision | Substantially Equivalent, Sep 12, 2000 |
| Received | May 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001642
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.