510(k) K991886

PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR by Pulsion Medical Systems, Inc. — Product Code KRB

K991886 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems, Inc. for the device "PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR". The FDA issued a decision of Substantially Equivalent on May 11, 2000. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Pulsion Medical Systems, Inc. has at least 7 other 510(k) clearances on record.