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

CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box is an FDA 510(k)-cleared medical device (K152582) manufactured by Volcano Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 2015. Regulation: 8.