510(k) K031694 ยท OLW Index-Generating Electroencephalograph Software
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
| Applicant | Aspect Medical Systems, Inc., Lafayette CO, US |
| Decision | Substantially Equivalent, Aug 29, 2003 |
| Received | Jun 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031694
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.