510(k) K072735

PULSION PICCO-2, MODEL 8500 by Pulsion Medical Systems AG — Product Code DXG

K072735 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems AG for the device "PULSION PICCO-2, MODEL 8500". The FDA issued a decision of Substantially Equivalent on October 18, 2007. 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.