510(k) K062592

CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE by Smiths Medical MD, Inc. — Product Code FRN

K062592 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE". The FDA issued a decision of Substantially Equivalent on November 29, 2006. 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.