Clear Guide SCENERGY

System, X-ray, Tomography, Computed

Clear Guide Medical

The following data is part of a premarket notification filed by Clear Guide Medical with the FDA for Clear Guide Scenergy.

Pre-market Notification Details

Device IDK201188
510k NumberK201188
Device Name:Clear Guide SCENERGY
ClassificationSystem, X-ray, Tomography, Computed
Applicant Clear Guide Medical 3600 Clipper Mill Road, Suite 400 Baltimore,  MD  21211
ContactJack Kent
CorrespondentJack Kent
Clear Guide Medical 3600 Clipper Mill Road, Suite 400 Baltimore,  MD  21211
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-09-30

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