510(k) K874546

SIM MODULE by Critikon Company, LLC — Product Code FRN

K874546 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "SIM MODULE". The FDA issued a decision of Substantially Equivalent on May 11, 1988. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Critikon Company, LLC has at least 10 other 510(k) clearances on record.