510(k) K043367 ยท GWE Stimulator, Photic, Evoked Response
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
| Applicant | Lace Electronica S.R.L., Clearwater FL, US |
| Decision | Substantially Equivalent, Nov 17, 2005 |
| Received | Dec 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043367
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.