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Mauna Kea Technologies

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K220477 Cellvizio 100 series system with confocal MiniprobesOWN2022-04-11 View
510(k) K212322 Cellvizio I.V.E. system with Confocal MiniprobesOWN2021-08-18 View
510(k) K193416 Cellvizio I.V.E. with Confocal MiniprobesOWN2020-02-28 View
510(k) K191144 Cellvizio 100 Series System with Confocal MiniprobesOWN2020-01-24 View
510(k) K183640 Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesOWN2019-02-22 View
510(k) K180270 Cellvizio 100 Series Systems with Confocal MiniprobesGWG2018-05-22 View
510(k) K172844 Cellvizio 100 Series System with Confocal MiniprobesOWN2017-12-15 View
510(k) K171345 Cellvizio 100 Series Systems with Confocal MiniprobesOWN2017-08-04 View
510(k) K160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesOWN2016-05-20 View
510(k) K123676 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBESOWN2013-04-18 View
510(k) K122042 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBESOWN2012-09-04 View
510(k) K120208 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBESOWN2012-04-20 View
510(k) K061666 CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEXGCJ2006-08-24 View
510(k) K051585 F-400 SYSTEMGCJ2005-09-06 View
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