510(k) K180162 ยท PSN Light Based Imaging
VivaScope System
| Applicant | Caliber Imaging & Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 3, 2018 |
| Received | Jan 19, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180162
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.