510(k) K190404 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
OTIS Optical Coherence Tomography SYstem
| Applicant | Perimeter Medical Imaging, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Mar 26, 2019 |
| Received | Feb 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190404
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.