510(k) K050835 ยท OLW Index-Generating Electroencephalograph Software
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
| Applicant | GE Healthcare, Needham MA, US |
| Decision | Substantially Equivalent, May 6, 2005 |
| Received | Apr 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050835
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.