510(k) K130565 ยท NQE Microscope, Specular
SPECULAR MICROSCOPE CEM-530
| Applicant | Nidek Co., Ltd., Andover MA, US |
| Decision | Substantially Equivalent, Nov 27, 2013 |
| Received | Mar 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130565
| 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.