AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is an FDA 510(k)-cleared medical device (K193509) manufactured by Acutus Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2020. Regulation: 8.