510(k) K150688 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
IdentEvent
| Applicant | Optima Neuroscience, Inc., Alachua FL, US |
| Decision | Substantially Equivalent, Nov 5, 2015 |
| Received | Mar 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150688
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.