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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K200560
Device Name InBody
Applicant
Inbody Co., Ltd.
Inbody Bldg., 625, Eonju-Ro, Gangnam-Gu
Seoul,  KR 06106
Applicant Contact Koeun Jung
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DXQ  
Date Received03/04/2020
Decision Date 01/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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