SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS

SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS is an FDA 510(k)-cleared medical device (K923875) manufactured by I-Flow Corp.. 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 May 12, 1993. Regulation: 8.