IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS

Monitor, Extracellular Fluid, Lymphedema, Extremity

IMPEDIMED PTY LTD.

The following data is part of a premarket notification filed by Impedimed Pty Ltd. with the FDA for Impedimed-extracellular Fluid Analysis.

Pre-market Notification Details

Device IDK050415
510k NumberK050415
Device Name:IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
ClassificationMonitor, Extracellular Fluid, Lymphedema, Extremity
Applicant IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS Brisbane, Queensland,  AU 4113
ContactNeville Bertwistle
CorrespondentNeville Bertwistle
IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS Brisbane, Queensland,  AU 4113
Product CodeOBH  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-18
Decision Date2007-03-30
Summary:summary

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