Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K150831
Cellvizio 100 Series System with Confocal Miniprobes · Mauna Kea Technologies · decided 2015-12-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| GastroFlex™ UHD | 211-0072 | MAUNA KEA TECHNOLOGIES | OWN | 03760187910079 |
| ColoFlex™ UHD | 211-0134 | MAUNA KEA TECHNOLOGIES | OWN | 03760187910055 |