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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 K060642
Device Name DUTECK BODY COMPOSITION ANALYZER
Applicant
Duteck Industrial Co., Ltd.
3f-2, # 26, 513 Ln.
Jui-Kuang Rd.
Taipei,  TW 114
Applicant Contact JOSEPH CHEN
Correspondent
Duteck Industrial Co., Ltd.
3f-2, # 26, 513 Ln.
Jui-Kuang Rd.
Taipei,  TW 114
Correspondent Contact JOSEPH CHEN
Regulation Number870.2770
Classification Product Code
MNW  
Date Received03/10/2006
Decision Date 06/07/2006
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
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