510(k) K191615 ยท NFJ System, Image Management, Ophthalmic
Huvitz Imaging System
| Applicant | Huvitz Co., Ltd., Anyang-Si, Dongan-Gu, KR |
| Decision | Substantially Equivalent, Jul 18, 2019 |
| Received | Jun 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191615
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.