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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K211159
Device Name eco-x Series (eco-x, eco-x-s)
Applicant
HDX WILL Corp.
#105,106,201,202,203,204,38,Osongsaengmyeong-4-ro
Osong-eup,Heungdeok-gu
Cheongju-si,  KR 28161
Applicant Contact Myoung-Joon Lee
Correspondent
HDX Will Corp.
03162 10F, 29, Insadong 5-gil
Jongno-gu,  KR 03162
Correspondent Contact Jeon Seounghwa
Regulation Number892.1750
Classification Product Code
OAS  
Date Received04/19/2021
Decision Date 12/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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