510(k) K132323 ยท OBO Tomography, Optical Coherence
RS-3000 ADVANCE
| Applicant | Nidek Co., Ltd., Wadsworth OH, US |
| Decision | Substantially Equivalent, Feb 19, 2014 |
| Received | Jul 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132323
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.