COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO

COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO is an FDA 510(k)-cleared medical device (K973864) manufactured by Pausch Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 1998. Regulation: 8.