510(k) K083063 ยท OLW Index-Generating Electroencephalograph Software
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
| Applicant | Mennen Medical , Ltd., Rohovot, IL |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Oct 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083063
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.