DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES

DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES is an FDA 510(k)-cleared medical device (K905111) manufactured by Eigen. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 24, 1991. Regulation: 8.