FDA 510(k) Applications Submitted by MAUNA KEA TECHNOLOGIES

FDA 510(k) Number Submission Date Device Name Applicant
K051585 06/15/2005 F-400 SYSTEM MAUNA KEA TECHNOLOGIES
K220477 02/18/2022 Cellvizio 100 series system with confocal Miniprobes Mauna Kea Technologies
K212322 07/26/2021 Cellvizio I.V.E. system with Confocal Miniprobes Mauna Kea Technologies
K061666 06/14/2006 CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX MAUNA KEA TECHNOLOGIES
K122042 07/12/2012 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K123676 11/30/2012 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K120208 01/24/2012 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K141358 05/23/2014 CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K133466 11/12/2013 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) MAUNA KEA TECHNOLOGIES
K150831 03/30/2015 Cellvizio 100 Series System with Confocal Miniprobes MAUNA KEA TECHNOLOGIES
K151593 06/12/2015 Cellvizio 100 Series System with Confocal Miniprobes MAUNA KEA TECHNOLOGIES
K180270 01/31/2018 Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies
K160416 02/16/2016 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes MAUNA KEA TECHNOLOGIES
K191144 04/30/2019 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies
K171345 05/08/2017 Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies
K172844 09/19/2017 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies
K193416 12/09/2019 Cellvizio I.V.E. with Confocal Miniprobes Mauna Kea Technologies
K183640 12/26/2018 Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes Mauna Kea Technologies


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