510(k) K030267 ยท OLW Index-Generating Electroencephalograph Software
EEG MONITOR WITH BIS, MODEL A-2000
| Applicant | Aspect Medical Systems, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Jan 15, 2004 |
| Received | Jan 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030267
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.