EVS 4343

Solid State X-ray Imager (flat Panel/digital Imager)

DRTECH Corporation

The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Evs 4343.

Pre-market Notification Details

Device IDK142475
510k NumberK142475
Device Name:EVS 4343
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant DRTECH Corporation Suite No.2, 3 Floor Dunchon-dacro541beon-gil Jungwon-gu Seongam-si,  KR 462-807
ContactChoul-woo Shin
CorrespondentChoul-woo Shin
DRTECH Corporation Suite No.2, 3 Floor Dunchon-dacro541beon-gil Jungwon-gu Seongam-si,  KR 462-807
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-03
Decision Date2015-01-15
Summary:summary

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