510(k) K020485

ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML by Baxter Healthcare Corp — Product Code KPE

K020485 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML". The FDA issued a decision of Substantially Equivalent on Mar 12, 2002. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxter Healthcare Corp has 507 other 510(k) clearances on record.