510(k) K011794 ยท GWE Stimulator, Photic, Evoked Response
XLTEK LED GOGGLES, MODEL LED-01
| Applicant | Excel Tech. , Ltd., Oakville, CA |
| Decision | Substantially Equivalent, Oct 1, 2001 |
| Received | Jun 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011794
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.