510(k) K173980 ยท NQE Microscope, Specular
Specular Microscope CEM-530
| Applicant | Nidek Co., Ltd., Gamagori, JP |
| Decision | Substantially Equivalent, Mar 14, 2018 |
| Received | Dec 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2019 | Nidek, Inc. NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Informati Terminated |
NQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.