510(k) K160416 ยท OWN Confocal Optical Imaging
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
| Applicant | Mauna Kea Technologies, Paris, FR |
| Decision | Substantially Equivalent, May 20, 2016 |
| Received | Feb 16, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160416
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.