510(k) K133132 ยท HJO Biomicroscope, Slit-Lamp, Ac-Powered
OPTICAL BIOMETER AL-SCAN
| Applicant | Nidek Co., Ltd., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 11, 2014 |
| Received | Sep 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2016 | Nidek Inc OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.
Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the po Terminated |
HJO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.