510(k) K061907 ยท OLW Index-Generating Electroencephalograph Software
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
| Applicant | GE Healthcare, Needham MA, US |
| Decision | Substantially Equivalent, Mar 27, 2008 |
| Received | Jul 5, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061907
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.