Cellvizio 100 Series Confocal Laser Imaging Systems And Their 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 Confocal Laser Imaging Systems And Their Confocal Miniprobes.

Pre-market Notification Details

Device IDK183640
510k NumberK183640
Device Name:Cellvizio 100 Series Confocal Laser Imaging Systems And Their 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  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-02-22
Summary:summary

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