PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

System, X-ray, Extraoral Source, Digital

VATECH CO., LTD.

The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Pch-2500 Digital Extraoral Source X-ray System, Pax-i Digital Extraoral Source X-ray System.

Pre-market Notification Details

Device IDK130585
510k NumberK130585
Device Name:PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant VATECH CO., LTD. 12946 KIMBERLEY LN Houston,  TX  77079
ContactDave Kim
CorrespondentDave Kim
VATECH CO., LTD. 12946 KIMBERLEY LN Houston,  TX  77079
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-05
Decision Date2013-07-15
Summary:summary

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