510(k) K040358 ยท GWF Stimulator, Electrical, Evoked Response
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
| Applicant | Excel Tech. , Ltd., Oakville, Ontario, CA |
| Decision | Substantially Equivalent, Aug 6, 2004 |
| Received | Feb 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2015 | Natus Medical Incorporated EPWorks software used in the Xltek Protektor Stimulator
Product Usage:
Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, s Terminated |
GWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.