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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 K110689
Device Name INBODY
Applicant
BIOSPACE CORPORATION LIMITED
8870 RAVELLO CT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
BIOSPACE CORPORATION LIMITED
8870 RAVELLO CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number870.2770
Classification Product Code
MNW  
Date Received03/15/2011
Decision Date 08/19/2011
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
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