510(k) K013087

SINGLE DOSE DISPENSING PIN, MODEL 2201 by Alaris Medical Systems, Inc. — Product Code LHI

K013087 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "SINGLE DOSE DISPENSING PIN, MODEL 2201". The FDA issued a decision of Substantially Equivalent on November 13, 2001. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.