510(k) K220955

Hudson RCI Variable concentration Large Volume Nebulizer (1770) by Medline Industires, Inc. — Product Code CAF

K220955 is an FDA 510(k) premarket notification submitted by Medline Industires, Inc. for the device "Hudson RCI Variable concentration Large Volume Nebulizer (1770)". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medline Industires, Inc. has at least 5 other 510(k) clearances on record.