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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 K062652
Device Name INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
Applicant
Tanita Corporation of America
2625 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Applicant Contact BETH MACKEY
Correspondent
Tanita Corporation of America
2625 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Correspondent Contact BETH MACKEY
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/07/2006
Decision Date 12/28/2006
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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