510(k) K050271 ยท HKI Camera, Ophthalmic, Ac-Powered
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
| Applicant | Kowa Co. , Ltd., Chuo-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, Nov 3, 2005 |
| Received | Feb 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050271
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.