EzRay Air 2 Wall (Model: VEX-S350W)

Unit, X-ray, Extraoral With Timer

Vatech Co., Ltd

The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Ezray Air 2 Wall (model: Vex-s350w).

Pre-market Notification Details

Device IDK223058
510k NumberK223058
Device Name:EzRay Air 2 Wall (Model: VEX-S350W)
ClassificationUnit, X-ray, Extraoral With Timer
Applicant Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactDaniel Kim
CorrespondentDave Kim
Mtech Group 7505 Fannin Street, Suite 610 Houston,  TX  77054
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-30
Decision Date2022-10-26

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