510(k) K982020

METRON QA-IDS I.V. PUMP TESTER by Metron U.S., Inc. — Product Code FRN

K982020 is an FDA 510(k) premarket notification submitted by Metron U.S., Inc. for the device "METRON QA-IDS I.V. PUMP TESTER". The FDA issued a decision of Substantially Equivalent on September 30, 1998. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Metron U.S., Inc. has at least 3 other 510(k) clearances on record.