510(k) K161829 ยท NFJ System, Image Management, Ophthalmic
Huvitz Imaging System
| Applicant | Huvitz Co., Ltd., Gunpo-Si, KR |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Jul 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161829
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.