510(k) K122121

PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE by Pulsion Medical Systems SE — Product Code DXG

K122121 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems SE for the device "PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE". The FDA issued a decision of Substantially Equivalent on August 2, 2012. 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 SE has at least 3 other 510(k) clearances on record.