510(k) K092039 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
IDENTEVENT, VERSION 1.0G
| Applicant | Optima Neuroscience, Inc., Newberry FL, US |
| Decision | Substantially Equivalent, Oct 16, 2009 |
| Received | Jul 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092039
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.