INBODY, MODEL 3.0

Analyzer, Body Composition

BIOSPACE CORPORATION LIMITED

The following data is part of a premarket notification filed by Biospace Corporation Limited with the FDA for Inbody, Model 3.0.

Pre-market Notification Details

Device IDK042528
510k NumberK042528
Device Name:INBODY, MODEL 3.0
ClassificationAnalyzer, Body Composition
Applicant BIOSPACE CORPORATION LIMITED PO BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
BIOSPACE CORPORATION LIMITED PO BOX 7007 Deerfield,  IL  60015
Product CodeMNW  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-17
Decision Date2005-01-11
Summary:summary

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