510(k) K944020

AIRSEP NEWLIFE AIR OUTLET OPTION by Airsep Corp. — Product Code CAF

K944020 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "AIRSEP NEWLIFE AIR OUTLET OPTION". The FDA issued a decision of Substantially Equivalent on March 16, 1995. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Airsep Corp. has at least 10 other 510(k) clearances on record.