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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K930599
Device Name BODY FAT ANALYZER MODEL TBF-105
Applicant
Tanita Corp. of America
5200 Church St.
Skokie,  IL  60077
Applicant Contact TOSHIHIKO OSHIMA
Correspondent
Tanita Corp. of America
5200 Church St.
Skokie,  IL  60077
Correspondent Contact TOSHIHIKO OSHIMA
Regulation Number870.2770
Classification Product Code
DSB  
Date Received02/05/1993
Decision Date 11/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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