510(k) K941151

STRATOFUSE PCA II INFUSER by Infusion Technology Intl. — Product Code FRN

K941151 is an FDA 510(k) premarket notification submitted by Infusion Technology Intl. for the device "STRATOFUSE PCA II INFUSER". The FDA issued a decision of Substantially Equivalent on July 7, 1994. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Infusion Technology Intl. has at least 2 other 510(k) clearances on record.