510(k) K001762

PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM by Pulsion Medical Systems, Inc. — Product Code DXG

K001762 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems, Inc. for the device "PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 2000. 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, Inc. has at least 7 other 510(k) clearances on record.