510(k) K010965 ยท OLW Index-Generating Electroencephalograph Software
A-LINE AEP MONITOR
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 27, 2001 |
| Received | Apr 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010965
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.