DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)

DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) is an FDA 510(k)-cleared medical device (K032331) manufactured by Pro-Med Instruments GmbH. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2003. Regulation: 8.