Requiring modifications to the following hemodialysis machines manufactured by Fresenius USA, Inc., in order to provide safer hemodialysis treatments for patients and consumers 2008K2 Hemodialysis Machines, cleared under 510(k) no. K153449; the 2008T Hemodialysis Machines, first cleared under 510(k) no. K173972. K080964; and the 2008T BlueStar Hemodialysis Machines, cleared under 510(k) no. K17397
🏛 Food and Drug Administration (FDA)FDA-2023-P-0219
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