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Nephros gets 510k approval from FDA for it's add-on hemodiafiltration module. |
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Sacramento Bee: Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications and advanced water purification solutions, today announced the Company has received 510(k) clearance from the Food and Drug Administration ("FDA") to market its Hemodiafiltration ("HDF") system for the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards in the United States.
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