H.E.A.R.T. NEBULIZER

H.E.A.R.T. NEBULIZER is an FDA 510(k)-cleared medical device (K900228) manufactured by B&B Medical Technologies, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 1990. Regulation: 8.