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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 K043060
Device Name OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
Applicant
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Applicant Contact LARRY LEPLEY
Correspondent
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Correspondent Contact LARRY LEPLEY
Regulation Number870.2770
Classification Product Code
MNW  
Date Received11/05/2004
Decision Date 01/19/2005
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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