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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 K030349
Device Name HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
Applicant
Bonso Electronics International, Inc.
719 A St. NE
Washington,  DC  20002
Applicant Contact RUSS PAGANO
Correspondent
Bonso Electronics International, Inc.
719 A St. NE
Washington,  DC  20002
Correspondent Contact RUSS PAGANO
Regulation Number870.2770
Classification Product Code
MNW  
Date Received02/03/2003
Decision Date 05/02/2003
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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