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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 K031167
Device Name HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
Applicant
Idt Technology Limited
Block C, 9/F., Kaiser Estate,
Phase 1, 41 Man Yue St.
Hunghom, Hong Kong,  CN
Applicant Contact STEPHEN LI
Correspondent
Idt Technology Limited
Block C, 9/F., Kaiser Estate,
Phase 1, 41 Man Yue St.
Hunghom, Hong Kong,  CN
Correspondent Contact STEPHEN LI
Regulation Number870.2770
Classification Product Code
MNW  
Date Received04/14/2003
Decision Date 01/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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