FUNHALER, MODEL FH 101

FUNHALER, MODEL FH 101 is an FDA 510(k)-cleared medical device (K042546) manufactured by Infamed , Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2005. Regulation: 8.