510(k) K010092 ยท GWF Stimulator, Electrical, Evoked Response
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
| Applicant | Excel Tech. , Ltd., Oakville, CA |
| Decision | Substantially Equivalent, Apr 2, 2001 |
| Received | Jan 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010092
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.