510(k) K012939

AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER by Monaghan Medical Corp. — Product Code CAF

K012939 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corp. for the device "AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER". The FDA issued a decision of Substantially Equivalent on September 28, 2001. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Monaghan Medical Corp. has at least 10 other 510(k) clearances on record.