510(k) K151706 ยท NQE Microscope, Specular
Specular Microscope CEM- 530
| Applicant | Nidek Co., Ltd., Gamagori, JP |
| Decision | Substantially Equivalent, Mar 17, 2016 |
| Received | Jun 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151706
| 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 |
| Sep 1, 2016 | Nidek Inc SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09.
Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observatio Terminated |
NQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.