Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400

FDA 510(k) K100811 · ImpediMed Limited

Substantially Equivalent

510(k) numberK100811

Submission

Device name
Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400
Applicant
ImpediMed Limited
San Diego, CA, US
Received
March 22, 2010
Decision date
November 4, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBH – Monitor, Extracellular Fluid, Lymphedema, Extremity
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)

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K130338Impedimed - Bis Extra Cellular Fluid AnalysisOBH · Traditional ImpediMed Limited05/31/2013SE
K080825Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400OBH · Traditional Impedimed Pty , Ltd.10/03/2008SESK
K050415Impedimed-Extracellular Fluid AnalysisOBH · Traditional Impedimed Pty , Ltd.03/30/2007SESK

More from Impedimed Pty , Ltd.

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K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional 08/17/2026SE
K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)OBH · Traditional 01/28/2026SE
K232089SOZO ProDSB · Traditional 10/17/2023SE
K230531SOZO ProQJB · Special 05/04/2023SE
K230530SOZO ProOBH · Special 05/04/2023SE
K203473SozoDSB · Traditional 04/19/2021SE
K193410SOZO Body Fluid AnalyzerDSB · Traditional 10/02/2020SE
K190529SozoQJB · Traditional 11/25/2019SE
K180126SozoOBH · Traditional 04/16/2018SE
K172507SozoDSB · Traditional 12/22/2017SE

Questions and answers

When was Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 cleared by the FDA?

Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 (K100811) received a 510(k) decision of Substantially Equivalent on November 4, 2011, 592 days after the submission was received.

What is the product code of K100811?

The FDA product code is OBH – Monitor, Extracellular Fluid, Lymphedema, Extremity, a Class II (moderate risk) device regulated under 21 CFR 870.2770.