BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)

BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) is an FDA 510(k)-cleared medical device (K050971) manufactured by Biovalve Technologies, 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 August 15, 2005. Regulation: 8.