510(k) K973218 ยท HKI Camera, Ophthalmic, Ac-Powered
NIDEK HANDY
| Applicant | Nidek, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Nov 4, 1997 |
| Received | Aug 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973218
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.