510(k) K083316 ยท OBO Tomography, Optical Coherence
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
| Applicant | Topcon Medical Systems, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Mar 13, 2009 |
| Received | Nov 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083316
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.