Agachamber Spacer

K101348 is the FDA 510(k) clearance record for AGACHAMBER SPACER, a class II device, cleared for Aga Plastic Ind. Com. Ltda. on 2011-04-29 under FDA product code NVP (Holding Chambers, Direct Patient Interface). FDA's definition for product code NVP reads: "Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient...". FDA records list 2 510(k) clearances for Aga Plastic Ind. Com. Ltda., from 1999-12-09 to 2011-04-29. As of 2026-09-10, FDA records show no recalls naming K101348.