AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION

AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION is an FDA 510(k)-cleared medical device (K904684) manufactured by Amici, Inc.. 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 13, 1991. Regulation: 8.