510(k) K921052

FRESENIUS VARIABLE FILL MONITOR by Fresenius USA, Inc. — Product Code KDJ

K921052 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "FRESENIUS VARIABLE FILL MONITOR". The FDA issued a decision of Substantially Equivalent on February 25, 1993. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.