510(k) K971685 ยท HKI Camera, Ophthalmic, Ac-Powered
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
| Applicant | Tomey Corporation USA, Washington DC, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | May 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971685
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.