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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 K033157
Device Name TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
Applicant
TANITA CORP. OF AMERICA
2625 SOUTH CLEARBROOK DR.
ARLINGTON HGTS.,  IL  60005
Applicant Contact RHODA LYNN VALERA
Correspondent
TANITA CORP. OF AMERICA
2625 SOUTH CLEARBROOK DR.
ARLINGTON HGTS.,  IL  60005
Correspondent Contact RHODA LYNN VALERA
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/30/2003
Decision Date 04/08/2004
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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