COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A

COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A is an FDA 510(k)-cleared medical device (K904070) manufactured by Kretztechnik AG. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 8, 1992. Regulation: 8.