510(k) K011534 ยท OLW Index-Generating Electroencephalograph Software
EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
| Applicant | Aspect Medical Systems, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Jun 15, 2001 |
| Received | May 18, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011534
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.