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modification to fresenius 2008t hemodialysis machine model 190573
Fresenius Medical Care North America
Summary: The Fresenius 2008T Hemodialysis Machine is used for hemodialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K093902 ↗
Decision Date
May 27, 2010
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Fresenius 2008T Hemodialysis Machine, manufactured by Fresenius Medical Care North America, received FDA clearance through the 510(k) pathway on May 27, 2010. It is classified as a Class 2 device under product code KDI.
What It Is
The Fresenius 2008T Hemodialysis Machine is a sophisticated medical device designed to perform hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are no longer able to do so effectively. This machine is equipped with advanced features to ensure precise control of dialysis parameters, enhancing patient safety and treatment efficacy. It includes components for blood and dialysate flow management, ultrafiltration control, and patient monitoring.
Clinical Applications
This device is commonly used in outpatient dialysis centers and hospital dialysis units to treat patients with chronic kidney disease (CKD) or acute kidney injury (AKI) requiring renal replacement therapy. Nephrologists and dialysis nurses utilize this machine to manage the dialysis treatment of adult and pediatric patients. It is essential in maintaining fluid and electrolyte balance in patients with end-stage renal disease (ESRD).
Indications for Use
The Fresenius 2008T Hemodialysis Machine is indicated for use in patients who require hemodialysis due to kidney failure. It is suitable for both chronic and acute conditions where the kidneys cannot adequately filter the blood.
Practical Considerations
The machine is compatible with standard hemodialysis consumables and can be adjusted to accommodate different patient sizes and treatment prescriptions. Regular maintenance and calibration are essential to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses in nephrology and renal care settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for hemodialysis treatment in patients with kidney failure, including those with chronic and acute conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.