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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K212144
Device Name Remex KA6
Applicant
Remedi Co., Ltd.
#1409, Is Biz Tower, 26 Yangpyeong-Ro 21-Gil
Seoul,  KR 072NN
Applicant Contact Suho Cho
Correspondent
510K FDA, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact W. Lee Strong
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/09/2021
Decision Date 08/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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