510(k) K013389 ยท OLW Index-Generating Electroencephalograph Software
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
| Applicant | Datex-Ohmeda, Needham MA, US |
| Decision | Substantially Equivalent, Jan 10, 2002 |
| Received | Oct 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013389
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.