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ED00120 Rev. A


The RenalGuard / RenalPro system and treatment have not been approved or cleared by the U.S. Food and Drug Administration (FDA). This device is currently available only for investigational use and is intended solely for use in clinical studies or other research settings under applicable regulatory guidelines.​ The system and treatment are CE approved for Fluid Balance Management. The system is branded as RenalGuard outside of the United States
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