510(k) K010315 ยท HKI Camera, Ophthalmic, Ac-Powered
ISCREEN VISION SCREENER
| Applicant | Iscreen, LLC, Memphis TN, US |
| Decision | Substantially Equivalent, Jun 1, 2001 |
| Received | Feb 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010315
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.