510(k) K943692

SMART DOSE(TM) by River Medical, Inc. — Product Code FRN

K943692 is an FDA 510(k) premarket notification submitted by River Medical, Inc. for the device "SMART DOSE(TM)". The FDA issued a decision of ST on April 28, 1995. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. River Medical, Inc. has at least 10 other 510(k) clearances on record.