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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 K963575
Device Name HBF-1000 OMRON BODY COMPOSITION ANALYZER
Applicant
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Applicant Contact EDWARD SIEMENS
Correspondent
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact EDWARD SIEMENS
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/06/1996
Decision Date 06/13/1997
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
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