510(k) K801381 ยท HPL Device, Fixation, Ac-Powered, Ophthalmic
FITE FIXATION TOY FOR OCULAR EXAM
| Applicant | Fite Engineering Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 28, 1980 |
| Received | Jun 11, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801381
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.