SENSI-CAL AMCO AEPA-1

SENSI-CAL AMCO AEPA-1 is an FDA 510(k)-cleared medical device (K935566) manufactured by Radiometer America, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 1994. Regulation: 8.