510(k) K040183 ยท OLW Index-Generating Electroencephalograph Software
BISX
| Applicant | Aspect Medical Systems, Inc., Lafayette CO, US |
| Decision | Substantially Equivalent, Feb 25, 2004 |
| Received | Jan 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040183
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.