510(k) K183320 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
Ilumien Optis, Optis Integrated, Optis Mobile
| Applicant | St. Jude Medical (Now Abbott Medical), St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 2, 2019 |
| Received | Nov 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183320
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.