Cellvizio 100 Series System With Confocal Miniprobes

Confocal Optical Imaging

Mauna Kea Technologies

The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cellvizio 100 Series System With Confocal Miniprobes.

Pre-market Notification Details

Device IDK191144
510k NumberK191144
Device Name:Cellvizio 100 Series System With Confocal Miniprobes
ClassificationConfocal Optical Imaging
Applicant Mauna Kea Technologies 9, Rue D'Enghien Paris,  FR 75010
ContactVeronique Dentan
CorrespondentMichael A. Daniel
Daniel & Daniel Consulting 340 Jones Lane Gardnerville,  NV  89460
Product CodeOWN  
Subsequent Product CodeGCJ
Subsequent Product CodeGWG
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-04-30
Decision Date2020-01-24
Summary:summary

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