510(k) K092477 ยท OMC Reduced- Montage Standard Electroencephalograph
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
| Applicant | Neurowave Systems, Inc., Cleveland Heights OH, US |
| Decision | Substantially Equivalent, Oct 29, 2010 |
| Received | Aug 12, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092477
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.