510(k) K915075

NEBULIZER (DIRECT PATIENT INTERFACE) by Medi Nuclear Corp., Inc. — Product Code CAF

K915075 is an FDA 510(k) premarket notification submitted by Medi Nuclear Corp., Inc. for the device "NEBULIZER (DIRECT PATIENT INTERFACE)". The FDA issued a decision of Substantially Equivalent on July 16, 1992. 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.