EzRay Air Portable (Model: VEX-P300)

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 Portable (model: Vex-p300).

Pre-market Notification Details

Device IDK200182
510k NumberK200182
Device Name:EzRay Air Portable (Model: VEX-P300)
ClassificationUnit, X-ray, Extraoral With Timer
Applicant Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactDaniel Kim
CorrespondentDave Kim
MtechGroup 7707 Fannin St., Ste. 200-Vlll Houston,  TX  77054
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-24
Decision Date2020-02-11

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