EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

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 4343a, Evs 4343ag, Evs 3643a, Evs 3643ag.

Pre-market Notification Details

Device IDK192400
510k NumberK192400
Device Name:EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si,  KR 13216
ContactChoul-woo Shin
CorrespondentChoul-woo Shin
DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si,  KR 13216
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-03
Decision Date2019-10-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800018405703 K192400 000
08800018405604 K192400 000
08800018405505 K192400 000
08800018405406 K192400 000

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