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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 K062603
Device Name BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
Applicant
BIOSPACE CORPORATION LIMITED
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
BIOSPACE CORPORATION LIMITED
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/01/2006
Decision Date 02/15/2007
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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