510(k) K093304 ยท GWF Stimulator, Electrical, Evoked Response
PROTEKTOR 32
| Applicant | Natus Medical, Inc., Oakville, CA |
| Decision | Substantially Equivalent, Aug 11, 2010 |
| Received | Oct 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093304
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2015 | Natus Medical Incorporated EPWorks software used in the Protektor 32
Product Usage:
Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation Terminated |
GWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.