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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K232670
Device Name HiCardi+ H100
Applicant
MEZOO Co., Ltd.
Rm. 808, 200 Gieopdosi-Ro Jijeong-Myeon
Wonju-Si,  KR 26354
Applicant Contact Junghwan Park
Correspondent
MEZOO Co., Ltd.
13th Floor, 443, Teheran-Ro, Gangnam-Gu
Seoul,  KR
Correspondent Contact Jessica Kim
Regulation Number870.2800
Classification Product Code
DSH  
Date Received09/01/2023
Decision Date 09/20/2024
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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