510(k) K900228

H.E.A.R.T. NEBULIZER by B&B Medical Technologies, Inc. — Product Code CAF

K900228 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "H.E.A.R.T. NEBULIZER". The FDA issued a decision of Substantially Equivalent on March 16, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.