510(k) K080743

LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP by Smiths Medical MD, Inc. — Product Code FRN

K080743 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on April 25, 2008. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.