CRITIKON 48-HOUR AIR ELIMINATING FILTER

CRITIKON 48-HOUR AIR ELIMINATING FILTER is an FDA 510(k)-cleared medical device (K861644) manufactured by Critikon Company, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1986. Regulation: 8.