Videa Caries Assist

Analyzer, Medical Image

VideaHealth, Inc

The following data is part of a premarket notification filed by Videahealth, Inc with the FDA for Videa Caries Assist.

Pre-market Notification Details

Device IDK213795
510k NumberK213795
Device Name:Videa Caries Assist
ClassificationAnalyzer, Medical Image
Applicant VideaHealth, Inc 19 Kingston St Bostong,  MA  02111
ContactFlorian Hill
CorrespondentDonna-bea Tillman
Biologics Consulting 1555 King St, Suite 300 Alexandria,  VA  22314
Product CodeMYN  
CFR Regulation Number892.2070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-06
Decision Date2022-04-21

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