EzRay M18 (Model: VMX-P400)

System, X-ray, Mobile

Vatech Co., Ltd

The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Ezray M18 (model: Vmx-p400).

Pre-market Notification Details

Device IDK213462
510k NumberK213462
Device Name:EzRay M18 (Model: VMX-P400)
ClassificationSystem, X-ray, Mobile
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 CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-27
Decision Date2022-02-11

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