510(k) K974496 ยท OLW Index-Generating Electroencephalograph Software
A-2000 EEG MONITOR WITH BIS
| Applicant | Aspect Medical Systems, Inc., Natick MA, US |
| Decision | Substantially Equivalent, Feb 6, 1998 |
| Received | Nov 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974496
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.