510(k) K152582

CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box by Volcano Corporation — Product Code DSK

K152582 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box". The FDA issued a decision of Substantially Equivalent on December 3, 2015. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Volcano Corporation has at least 10 other 510(k) clearances on record.