BIOSIGN STEAM-24 BIOLOGICAL INDICATOR

BIOSIGN STEAM-24 BIOLOGICAL INDICATOR is an FDA 510(k)-cleared medical device (K032723) manufactured by Getinge USA, Inc.. 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 September 30, 2003. Regulation: 8.