BODYMETRIX BX2000

Ultrasonic Body Composition Analyzer

INTELAMETRIX, INC

The following data is part of a premarket notification filed by Intelametrix, Inc with the FDA for Bodymetrix Bx2000.

Pre-market Notification Details

Device IDK082147
510k NumberK082147
Device Name:BODYMETRIX BX2000
ClassificationUltrasonic Body Composition Analyzer
Applicant INTELAMETRIX, INC 6246 PRESTON AVENUE Livermore,  CA  94551
ContactHeidi Stark
CorrespondentHeidi Stark
INTELAMETRIX, INC 6246 PRESTON AVENUE Livermore,  CA  94551
Product CodeOMV  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-30
Decision Date2009-03-20
Summary:summary

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