510(k) K020357

800 SERIES EASYNEB NEBULIZER by Nellcor Puritan Bennett, Inc. — Product Code CAF

K020357 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "800 SERIES EASYNEB NEBULIZER". The FDA issued a decision of Substantially Equivalent on August 7, 2002. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Nellcor Puritan Bennett, Inc. has at least 10 other 510(k) clearances on record.