510(k) K153239 ยท HKI Camera, Ophthalmic, Ac-Powered
LSFG-NAVI
| Applicant | Softcare Co., Ltd., Fukutsu, JP |
| Decision | Substantially Equivalent, May 12, 2016 |
| Received | Nov 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153239
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.