Green X 18(Model : PHT-75CHS)

X-ray, Tomography, Computed, Dental

Vatech Co., Ltd

The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Green X 18(model : Pht-75chs).

Pre-market Notification Details

Device IDK210329
510k NumberK210329
Device Name:Green X 18(Model : PHT-75CHS)
ClassificationX-ray, Tomography, Computed, Dental
Applicant Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactDaniel Kim
CorrespondentDave Kim
Mtech Group 7707 Fannin St., Ste. 200-Vlll Houston,  TX  77054
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-04
Decision Date2021-02-18

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