510(k) K012262

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC by National Custom Ent., Inc. — Product Code MRZ

K012262 is an FDA 510(k) premarket notification submitted by National Custom Ent., Inc. for the device "BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC". The FDA issued a decision of Substantially Equivalent on September 12, 2001. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. National Custom Ent., Inc. has at least 10 other 510(k) clearances on record.