510(k) K052362 ยท OLW Index-Generating Electroencephalograph Software
BIS EEG MONITOR, MODEL A-3000
| Applicant | Aspect Medical Systems, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Sep 9, 2005 |
| Received | Aug 29, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052362
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.