510(k) K052145 ยท OLW Index-Generating Electroencephalograph Software
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
| Applicant | GE Healthcare, Needham MA, US |
| Decision | Substantially Equivalent, Aug 23, 2005 |
| Received | Aug 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052145
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.