HAFCON (FLOURO FOOTSWITCH)

HAFCON (FLOURO FOOTSWITCH) is an FDA 510(k)-cleared medical device (K901671) manufactured by B & H Research Instruments. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 1990. Regulation: 8.