Clio Prime And Clio Pedo

System, X-ray, Extraoral Source, Digital

Sota Precision Optics, Inc. Dba SOTA Imaging

The following data is part of a premarket notification filed by Sota Precision Optics, Inc. Dba Sota Imaging with the FDA for Clio Prime And Clio Pedo.

Pre-market Notification Details

Device IDK202664
510k NumberK202664
Device Name:Clio Prime And Clio Pedo
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant Sota Precision Optics, Inc. Dba SOTA Imaging 1073 North Batavia Street, Suite B Orange,  CA  92867
ContactBumsuk Kim
CorrespondentEd Johansen
W. Edward Johansen 1239 Stanford Street, #205 Santa Monica,  CA  90404
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-14
Decision Date2020-11-06

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