510(k) K041897 ยท HAW Neurological Stereotaxic Instrument
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
| Applicant | Schaerer Mayfield USA, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 1, 2005 |
| Received | Jul 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041897
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.