510(k) K911106

MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG by Baxter Healthcare Corp — Product Code KOC

K911106 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG". The FDA issued a decision of Substantially Equivalent on May 28, 1991. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.