510(k) K082541

HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM by Medi Nuclear Corp., Inc. — Product Code CAF

K082541 is an FDA 510(k) premarket notification submitted by Medi Nuclear Corp., Inc. for the device "HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 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.