510(k) K052981 ยท OLW Index-Generating Electroencephalograph Software
BIS EEG MONITOR, MODEL BISX4
| Applicant | Aspect Medical Systems, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Nov 1, 2005 |
| Received | Oct 24, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052981
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.