510(k) K842289

SR- MODEL 230 by Hirata Sangyo Co. USA, Inc. — Product Code FRN

K842289 is an FDA 510(k) premarket notification submitted by Hirata Sangyo Co. USA, Inc. for the device "SR- MODEL 230". The FDA issued a decision of Substantially Equivalent on July 25, 1984. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Hirata Sangyo Co. USA, Inc. has at least 7 other 510(k) clearances on record.