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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 K100183
Device Name MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
Applicant
TANITA CORP.
2625 SOUTH CLEARBROOK DRIVE
ARLINGTON HEIGHTS,  IL  60005
Applicant Contact TOSHISHIKO ISHIKAWA
Correspondent
TANITA CORP.
2625 SOUTH CLEARBROOK DRIVE
ARLINGTON HEIGHTS,  IL  60005
Correspondent Contact TOSHISHIKO ISHIKAWA
Regulation Number870.2770
Classification Product Code
MNW  
Date Received01/21/2010
Decision Date 04/15/2011
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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