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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K133466

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) · Mauna Kea Technologies · decided 2014-07-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
AveoFlex™-C211-0153MAUNA KEA TECHNOLOGIESOWN03760187910192
Cellvizio® 100 series (785nm)210-0031MAUNA KEA TECHNOLOGIESOWN03760187911014
GastroFlex™UHD-C211-0152MAUNA KEA TECHNOLOGIESOWN03760187910246