Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K122042
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES · Mauna Kea Technologies · decided 2012-09-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CholangioFlex™ | 211-0112 | MAUNA KEA TECHNOLOGIES | OWN | 03760187910031 |