510(k) K772072

MANIFOLD & NEBU. FOR DOUB. LINE MACH. by Inspiron Corp. — Product Code CAF

K772072 is an FDA 510(k) premarket notification submitted by Inspiron Corp. for the device "MANIFOLD & NEBU. FOR DOUB. LINE MACH.". The FDA issued a decision of Substantially Equivalent on November 15, 1977. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Inspiron Corp. has at least 10 other 510(k) clearances on record.