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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ultrasonic body composition analyzer
510(k) Number K082147
Device Name BODYMETRIX BX2000
Applicant
INTELAMETRIX, INC
6246 PRESTON AVENUE
LIVERMORE,  CA  94551
Applicant Contact HEIDI STARK
Correspondent
INTELAMETRIX, INC
6246 PRESTON AVENUE
LIVERMORE,  CA  94551
Correspondent Contact HEIDI STARK
Regulation Number870.2770
Classification Product Code
OMV  
Date Received07/30/2008
Decision Date 03/20/2009
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
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