510(k) K020587

PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 by Pulsion Medical Systems AG — Product Code KRB

K020587 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems AG for the device "PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046". The FDA issued a decision of Substantially Equivalent on May 23, 2002. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Pulsion Medical Systems AG has at least 7 other 510(k) clearances on record.