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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 K014009
Device Name TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE
Applicant
TANITA CORP. OF AMERICA
2625 SOUTH CLEARBROOK DR.
ARLINGTON HGTS.,  IL  60005
Applicant Contact CAROL ALLOIAN (BENSON)
Correspondent
TANITA CORP. OF AMERICA
2625 SOUTH CLEARBROOK DR.
ARLINGTON HGTS.,  IL  60005
Correspondent Contact CAROL ALLOIAN (BENSON)
Regulation Number870.2770
Classification Product Code
MNW  
Date Received12/05/2001
Decision Date 06/24/2002
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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