Mauna Kea Technologies · Class II · Cleared May 20, 2016
| K-number | K160416 |
| Device name | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes |
| Applicant | Mauna Kea Technologies |
| Product code | OWN |
| Device class | Class II |
| Decision date | May 20, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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