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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 K171137
Device Name EVS 2430W, EVS 2430GW
Applicant
DRTECH Corporation
Suite No. 2, 3 Floor, 29
Dunchon-daero541 beon-gil, Jungwon-gu
Seongnam-si,  KR 13230
Applicant Contact Choul-Woo Shin
Correspondent
DRTECH Corporation
Suite No. 2, 3 Floor, 29
Dunchon-daero541 beon-gil, Jungwon-gu
Seongnam-si,  KR 13230
Correspondent Contact Choul-Woo Shin
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/17/2017
Decision Date 05/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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