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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Body Composition
510(k) Number K092786
Device Name INBODY, MODELS: 270, R20, R20B
Applicant
Biospace Corporation Limited
8726 Ferrara Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Biospace Corporation Limited
8726 Ferrara Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/10/2009
Decision Date 03/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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