SOZO Body Fluid Analyzer

Plethysmograph, Impedance

ImpediMed Limited

The following data is part of a premarket notification filed by Impedimed Limited with the FDA for Sozo Body Fluid Analyzer.

Pre-market Notification Details

Device IDK193410
510k NumberK193410
Device Name:SOZO Body Fluid Analyzer
ClassificationPlethysmograph, Impedance
Applicant ImpediMed Limited Unit 1, 50 Parker Court Pinkenba,  AU 4008
ContactCatherine Kingsford
CorrespondentReuben Lawson
ImpediMed Inc. 5900 Pasteur Court, Unit 125 Carlsbad,  CA  92008
Product CodeDSB  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-10-02

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