FDA 510(k) approval for Fresenius:
This article was originally published in Clinica
Executive Summary
Fresenius USA's On Line Clearance monitor has received a 510(k) marketing clearance from the FDA. Used in conjunction with hemodialysis equipment, the device monitors the dose of dialysis achieved for end-stage renal disease patients during renal replacement therapy. This allows immediate treatment adjustment and eliminates monthly blood treatment sampling and testing for results. Fresenius USA is a subsidiary of Fresenius Medical North America.
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