CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

About This 510(k) Submission

K152582 is an FDA 510(k) clearance for the CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on December 3, 2015, 84 days after receiving the submission on September 10, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.