510(k) K831897

BETA I PROGRAMMABLE INFUSION PUMP by Orange Medical Instruments, Inc. — Product Code FRN

K831897 is an FDA 510(k) premarket notification submitted by Orange Medical Instruments, Inc. for the device "BETA I PROGRAMMABLE INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Orange Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.