Eco-x Series (eco-x, Eco-x-s)

X-ray, Tomography, Computed, Dental


The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Eco-x Series (eco-x, Eco-x-s).

Pre-market Notification Details

Device IDK211159
510k NumberK211159
Device Name:Eco-x Series (eco-x, Eco-x-s)
ClassificationX-ray, Tomography, Computed, Dental
Applicant HDX WILL Corp. #105,106,201,202,203,204,38,Osongsaengmyeong-4-ro Osong-eup,Heungdeok-gu Cheongju-si,  KR 28161
ContactMyoung-joon Lee
CorrespondentJeon Seounghwa
HDX Will Corp. 03162 10F, 29, Insadong 5-gil Jongno-gu,  KR 03162
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-19
Decision Date2021-12-30

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