510(k) K080657

NEB-90 LARGE VOLUME MEDICATION NEBULIZER by Medi Nuclear Corp., Inc. — Product Code CAF

K080657 is an FDA 510(k) premarket notification submitted by Medi Nuclear Corp., Inc. for the device "NEB-90 LARGE VOLUME MEDICATION NEBULIZER". The FDA issued a decision of Substantially Equivalent on June 30, 2008. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medi Nuclear Corp., Inc. has at least 8 other 510(k) clearances on record.