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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K192400
Device Name EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
Applicant
DRTECH Corporation
Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29,
Dunchon-daero541 beon-gil,
Jungwon-gu, Seongam-si,  KR 13216
Applicant Contact Choul-Woo Shin
Correspondent
DRTECH Corporation
Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29,
Dunchon-daero541 beon-gil,
Jungwon-gu, Seongam-si,  KR 13216
Correspondent Contact Choul-Woo Shin
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/03/2019
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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