510(k) K901114

MEDISONIC HUMDIFIER/INHALER by Medisonic U.S.A., Inc. — Product Code CAF

K901114 is an FDA 510(k) premarket notification submitted by Medisonic U.S.A., Inc. for the device "MEDISONIC HUMDIFIER/INHALER". The FDA issued a decision of Substantially Equivalent on May 22, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medisonic U.S.A., Inc. has at least 4 other 510(k) clearances on record.