510(k) K000842

CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM by Sims Deltec, Inc. — Product Code FRN

K000842 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 8, 2000. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.