Cellvizio I.V.E. 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 I.v.e. System With Confocal Miniprobes.

Pre-market Notification Details

Device IDK212322
510k NumberK212322
Device Name:Cellvizio I.V.E. System With Confocal Miniprobes
ClassificationConfocal Optical Imaging
Applicant Mauna Kea Technologies 9 Rue D'Enghien Paris,  FR 75010
ContactAline Criton
CorrespondentMichael A. Daniel
Daniel & Daniel Consulting 340 Jones Lane Gardnerville,  NV  89460
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-07-26
Decision Date2021-08-18

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