CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)

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 (tm).

Pre-market Notification Details

Device IDK133466
510k NumberK133466
Device Name:CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
ClassificationConfocal Optical Imaging
Applicant MAUNA KEA TECHNOLOGIES 8 SNOWBERRY COURT Orinda,  CA  94563
ContactMichael A Daniel
CorrespondentMichael A Daniel
MAUNA KEA TECHNOLOGIES 8 SNOWBERRY COURT Orinda,  CA  94563
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-12
Decision Date2014-07-25
Summary:summary

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