510(k) K080969

HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 by Medi Nuclear Corp., Inc. — Product Code CAF

K080969 is an FDA 510(k) premarket notification submitted by Medi Nuclear Corp., Inc. for the device "HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510". The FDA issued a decision of Substantially Equivalent on July 25, 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.