510(k) K963644 ยท OLW Index-Generating Electroencephalograph Software
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
| Applicant | Aspect Medical Systems, Inc., Natick MA, US |
| Decision | Substantially Equivalent, Oct 8, 1996 |
| Received | Sep 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963644
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.