510(k) K863532

MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER by Parker Hannifin Corp. — Product Code FRN

K863532 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corp. for the device "MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER". The FDA issued a decision of Substantially Equivalent on January 14, 1987. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Parker Hannifin Corp. has at least 8 other 510(k) clearances on record.