510(k) K994218

EASY CARE AND TUBING SETS by Medionics International, Inc. — Product Code FKX

K994218 is an FDA 510(k) premarket notification submitted by Medionics International, Inc. for the device "EASY CARE AND TUBING SETS". The FDA issued a decision of Substantially Equivalent on February 10, 2000. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Medionics International, Inc. has at least 9 other 510(k) clearances on record.