510(k) K060898

PULSION PICCO PLUS, MODEL 8100 by Pulsion Medical Systems AG — Product Code DXG

K060898 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems AG for the device "PULSION PICCO PLUS, MODEL 8100". The FDA issued a decision of Substantially Equivalent on July 25, 2006. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Pulsion Medical Systems AG has at least 7 other 510(k) clearances on record.