510(k) K182616 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
| Applicant | Ninepoint Medical, Inc., Bedford MA, US |
| Decision | Unknown, Nov 2, 2018 |
| Received | Sep 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182616
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.