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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K232823
Device Name MCG-S (AM1000)
Applicant
Amcg Co., Ltd.
F8, 156, Seochojungang-Ro, Seocho-Gu
Seoul,  KR 06605
Applicant Contact Soyeon Kim
Correspondent
Amcg Co., Ltd.
F8, 156, Seochojungang-Ro, Seocho-Gu
Seoul,  KR 06605
Correspondent Contact Soyeon Kim
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/13/2023
Decision Date 04/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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