510(k) K012466 ยท OLW Index-Generating Electroencephalograph Software
BIS/EEG MODULE
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Oct 1, 2001 |
| Received | Aug 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012466
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.